Is this your brand? Sign in to claim ownership.

Bard Peripheral Vascular

United States·US-MF-000017556

Last updated September 17, 2026

What Bard Peripheral Vascular makes

Bard Peripheral Vascular makes medical devices such as peripheral angioplasty balloon catheters, bare-metal biliary stents, peripheral artery stents, synthetic vascular grafts, and cardiovascular patches. Their products also include side-notch biopsy gun handpieces, cardiac valvuloplasty catheters, and vascular guide-catheters. Examples of their devices include the EleVation, Highlander, and LifeStar Vascular & Biliary Stent.

The company's portfolio is regulated under Class I, Class II, and Class III devices and is listed in the FDA UDI registry. The company is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What type of devices does Bard Peripheral Vascular make?

Bard Peripheral Vascular makes medical devices such as peripheral angioplasty balloon catheters and bare-metal biliary stents, among others, to support vascular health.

Where is Bard Peripheral Vascular based?

The company is based in the US, indicating its primary location for operations.

How are Bard Peripheral Vascular's devices classified?

Their devices are classified under Class I, Class II, and Class III, reflecting varying levels of regulatory control.

Which registry lists Bard Peripheral Vascular's devices?

The company's devices are listed in the FDA UDI registry, which tracks unique device identifiers for medical devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 1625 W. 3rd Street, Tempe, United States
Website: bd.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 (480) 894-9515
PRRC Contact: Emily Harris
EUDAMED SRN: US-MF-000017556
FDA FEI Number: 2020394
DUNS Number: —

Catalogue (3234)

Page 25 of 65

Device	Model / Reference	Registries	Class	Status
IMPRA® ePTFE Vascular Grafts	70T74TWC	FDA UDI	Class II	Active
Dynaflo® Bypass Grafts	DNF7007SC	FDA UDI	Class II	Unknown
LifeStent® Solo Vascular Stent	EX071703CL	FDA UDI	Class III	Active
True Dilatation	T234512	FDA UDI	Class II	Active
Venaflo® II ePTFE Vascular Grafts	CVLT4547C	FDA UDI	Class II	Active
E·Luminexx® Biliary Stent	ZBL12060	FDA UDI	Class II	Active
LifeStar® Vascular & Biliary Stent	VIUL07100	FDA UDI	Class III	Active
Ultraverse® 035 PTA Dilatation Catheter	U357592	FDA UDI	Class II	Active
Ultraverse® 014	U41001H10	FDA UDI	Class II	Active
LifeStent® XL Vascular & Biliary Stent System	EX051003CS	FDA UDI	Class III	Active
Ultraverse® 035 PTA Dilatation Catheter	U3510058	FDA UDI	Class II	Active
Highlander	H47526	FDA UDI	Class II	Active
Bard®	000681	FDA UDI	Class II	Unknown
LifeStent® Solo Vascular Stent	EX060602CL	FDA UDI	Class III	Active
Ultraverse® 035 PTA Dilatation Catheter	U3513052	FDA UDI	Class II	Active
Dorado®	DR13572	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3540106	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U35130530	FDA UDI	Class II	Active
Dorado®	DR8054	FDA UDI	Class II	Active
LifeStent® Solo Vascular Stent	EX061502CL	FDA UDI	Class III	Active
E-Luminexx® Vascular & Biliary Stent	ZBL10060	FDA UDI	Class II	Active
Flair® Endovascular Stent Graft	FAF08050	FDA UDI	Class III	Unknown
Ultraverse® RX	U41501Q2RX	FDA UDI	Class II	Active
VascuTrak®	V186080	FDA UDI	Class II	Unknown
Ultraverse® RX	U4801Q1HRX	FDA UDI	Class II	Active
LifeStar® Biliary Stent	VIUS14100	FDA UDI	Class II	Active
Ultrascore	US35130812	FDA UDI	Class II	Active
Conquest® 40	CQF75610	FDA UDI	Class II	Active
Ultraverse® 014	U4100430	FDA UDI	Class II	Active
Ultrascore	US3513062	FDA UDI	Class II	Active
Flair® Endovascular Stent Graft	FAS06050	FDA UDI	Class III	Unknown
Bard®	000673	FDA UDI	Class II	Unknown
Ultraverse® 018	U875230	FDA UDI	Class II	Unknown
Ultraverse® 014	U41503H2	FDA UDI	Class II	Active
Venaflo® II ePTFE Vascular Grafts	VLT2046C	FDA UDI	Class II	Active
LifeStent® Solo Vascular Stent	EX071701CL	FDA UDI	Class III	Active
LifeStar® Biliary Stent	VIUS12060	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U35100910	FDA UDI	Class II	Active
Highlander	H41302H8	FDA UDI	Class II	Active
Ultraverse® 018	U815034	FDA UDI	Class II	Active
Max-Core	MC1616	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3515062	FDA UDI	Class II	Active
Ultraverse® RX	U480420RX	FDA UDI	Class II	Active
Dorado®	DR135415	FDA UDI	Class II	Active
Ultraverse® 018	U87566	FDA UDI	Class II	Active
Highlander	H4100412	FDA UDI	Class II	Active
Bard® PTFE Thick Felt Pledgets	007971	FDA UDI	Class II	Active
Vida	VDA100182	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3515032	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3540121	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Bard Peripheral Vascular has 228 FDA recall records spanning from August 20, 2003, to November 14, 2023, with statuses including completed, open, classified, and terminated. Recalled products involve issues such as leaks, suction failures, signal loss during procedures, activation malfunctions, labeling inaccuracies (e.g., mislabeled graft sizes and balloon diameters), missing instructions for use (IFU), and mechanical defects (e.g., stopcock cracking, catheter breakage, and exposed sample chambers). Some recalls address compliance gaps, such as distribution without premarket notification, while others cite manufacturing or design-related concerns, including continuous operation risks and missing contraindications in IFUs.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 14, 2023	Z-0676-2024	—	open, classified	Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Nov 8, 2023	Z-0643-2024	—	open, classified	The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Aug 10, 2023	Z-0027-2024	—	open, classified	Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) from properly fitting into the coaxial cannula and accessing target tissue, which may lead to repeated procedure, and procedural complications, such as pain/discomfort, pneumothorax, and bleeding.
Apr 11, 2023	Z-1564-2023	—	open, classified	Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
Feb 28, 2023	Z-1260-2023	—	open, classified	The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Jan 4, 2023	Z-1051-2023	—	open, classified	Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).
Dec 22, 2022	Z-1108-2023	—	open, classified	An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Apr 22, 2022	Z-1273-2022	—	open, classified	There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Jan 20, 2022	Z-0800-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0792-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0797-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0799-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0795-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0798-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0794-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0791-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0796-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0790-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Jan 20, 2022	Z-0793-2022	—	open, classified	Due to lumbar puncture tray manometer failure mode of leaking and mating issues.
Aug 24, 2021	Z-0154-2022	—	terminated	Due to misbranded products shipped to customers.
Aug 24, 2021	Z-0153-2022	—	terminated	Due to misbranded products shipped to customers.
Jul 27, 2021	Z-0002-2022	—	open, classified	Potential for needle protector to become fully dislodge exposing infusion needle which could result in needle stick.
Jun 23, 2021	Z-2249-2021	—	open, classified	Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Jun 23, 2021	Z-2248-2021	—	open, classified	Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Jun 23, 2021	Z-2247-2021	—	open, classified	Due to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile.
Mar 25, 2021	Z-1550-2021	—	terminated	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Mar 25, 2021	Z-1552-2021	—	terminated	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Mar 25, 2021	Z-1551-2021	—	terminated	Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Jan 14, 2021	Z-1289-2021	—	terminated	Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
Dec 14, 2020	Z-1899-2021	—	open, classified	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Dec 14, 2020	Z-1897-2021	—	open, classified	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Dec 14, 2020	Z-1898-2021	—	open, classified	Reports of the proximal end of the stent not immediately expanding upon deployment and remaining connected to the delivery system.
Oct 1, 2020	Z-0080-2021	—	terminated	Dilation catheter packaged with the wrong size balloon. The labeling states that the balloon size is 6mm x 40mm, however included is a 5mm x 40mm balloon. Use of a balloon that has a smaller diameter than expected could result in inconsequential prolongation of an existing procedure.
Mar 17, 2020	Z-1689-2020	—	terminated	Sterility compromised due to packaging pouches that may not be sealed properly
Jan 15, 2020	Z-1964-2020	—	open, classified	The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
Jan 3, 2020	Z-1433-2020	—	terminated	Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020	Z-1434-2020	—	terminated	Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020	Z-1431-2020	—	terminated	Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Jan 3, 2020	Z-1432-2020	—	terminated	Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Oct 25, 2019	Z-0724-2020	—	terminated	During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Samples.
Oct 1, 2019	Z-1570-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1574-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1576-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1578-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1573-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1575-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1579-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1571-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1577-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Oct 1, 2019	Z-1572-2020	—	terminated	Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Aug 14, 2019	Z-0917-2020	—	terminated	The catheter packaging incorrectly listed the balloon size as 8mm X 20mm instead of the intended size 8mm X 40mm. If undetected, the user will advance the longer than expected balloon to the lesion. The potential exists that upon inflation, non-diseased vessel, kidney or sections of the AV dialysis fistulae may be dilated, potentially causing a varying degree of injury. This may require additional medical or surgical intervention.
Jun 14, 2019	Z-2209-2020	—	terminated	Incorrect Peel-Apart Introducer Sheath in Kit.
Jun 14, 2019	Z-2208-2020	—	terminated	Incorrect Peel-Apart Introducer Sheath in Kit.
May 31, 2019	Z-2391-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2387-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2377-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2381-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2394-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2373-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2392-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2382-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2372-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2378-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2370-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2388-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2374-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2368-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2393-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2395-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2385-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2375-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2389-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2384-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2371-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2379-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2376-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2383-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2386-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2380-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2369-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 31, 2019	Z-2390-2019	—	terminated	The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.
May 2, 2019	Z-2210-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019	Z-2213-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019	Z-2209-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019	Z-2212-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019	Z-2214-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
May 2, 2019	Z-2211-2019	—	terminated	There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples while using the product.
Apr 12, 2019	Z-1637-2020	—	terminated	The firm has become aware of a potential problem with their venous and arterial magnetic catheters may be at risk of experiencing a magnetic deficiency, which may result in the magnets failing to attract to one another. This may result in procedural delay in obtaining or creating a functional fistula and need for additional contrast to perform the necessary fluoroscopy. This can pose an incremental risk of harm to a diabetic patient's kidney function.
Feb 18, 2019	Z-0718-2020	—	terminated	Certain product code/lot number combinations may experience introducer sheath compatibility issues when used with a 6F introducer sheath. Using the affected balloon expandable vascular covered stents with a 6F introducer sheath could result in difficulty or the inability to insert or advance the catheter through the introducer sheath. This could potentially lead to a slight prolongation of the procedure.
Feb 14, 2019	Z-0582-2020	—	open, classified	Complaints received that products packaged with the incorrect introducer sheath size.
Jun 25, 2018	Z-2080-2019	—	completed	Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Apr 16, 2018	Z-1802-2018	—	terminated	Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Apr 16, 2018	Z-1803-2018	—	terminated	Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.
Feb 8, 2018	Z-1760-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1770-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1772-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1766-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1765-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1761-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.
Feb 8, 2018	Z-1771-2018	—	completed	The Patient ID Card packaged with the POWERPORT ClearVUE Implantable Port with Smooth Septum contains incorrect port flushing instructions.