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Bard Peripheral Vascular

United States·US-MF-000017556

Last updated September 17, 2026

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 8 of 65

Device	Model / Reference	Registries	Class	Status
Ultraverse® 014	U410032	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U35150310	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3515046	FDA UDI	Class II	Active
Bard® DeBakey® Elastic Knit Fabric	007830	FDA UDI	Class II	Unknown
Ultraverse® 035 PTA Dilatation Catheter	U3540310	FDA UDI	Class II	Active
GlidePath	5373120	FDA UDI	Class II	Active
Ultraverse® 018	U81502H10	FDA UDI	Class II	Active
Conquest® 40	CQF7582	FDA UDI	Class II	Active
Ultraverse® 018	U87584	FDA UDI	Class II	Active
LifeStent® XL Vascular & Biliary Stent	EX071003CS	FDA UDI	Class III	Active
Highlander	H413044	FDA UDI	Class II	Active
AV Sheath Tunneler	AVST0100	FDA UDI	Class II	Unknown
GlidePath	5347350	FDA UDI	Class II	Active
LifeStent® Vascular & Biliary Stent System	EX050401CS	FDA UDI	Class II	Active
Vida®	BAV184008	FDA UDI	Class II	Active
Ultraverse® RX	U480515RX	FDA UDI	Class II	Active
Dorado®	DR4082	FDA UDI	Class II	Active
LifeStar® Vascular & Biliary Stent	VIUL09100	FDA UDI	Class II	Active
Conquest®	CQ75122	FDA UDI	Class II	Active
Ultraverse® RX	U42001H8RX	FDA UDI	Class II	Active
Venaflo® ePTFE Vascular Grafts	V5006C	FDA UDI	Class II	Unknown
Ultraverse® 018	U8150310	FDA UDI	Class II	Active
Dorado®	DR4062	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U35130812	FDA UDI	Class II	Active
E-Luminexx® Vascular & Biliary Stent	ZBL09020	FDA UDI	Class III	Active
Ultraverse® RX	U4200512RX	FDA UDI	Class II	Unknown
Dorado®	DR13568	FDA UDI	Class II	Active
Ultraverse® 014	U4130222	FDA UDI	Class II	Active
Ultraverse® RX	U480330RX	FDA UDI	Class II	Active
Sidekick®	SD70TG	FDA UDI	Class II	Active
VascuTrak®	V1840120	FDA UDI	Class II	Unknown
Ultraverse® 018	U820054	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U3575515	FDA UDI	Class II	Active
Highlander	H4753H4	FDA UDI	Class II	Active
Ultraverse® 014	U415022	FDA UDI	Class II	Active
Rival®	RV13556	FDA UDI	Class II	Unknown
Atlas® Gold	ATG80182	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U354072	FDA UDI	Class II	Active
Rival®	RV8092	FDA UDI	Class II	Unknown
Ultraverse® RX	U48038RX	FDA UDI	Class II	Active
Ultraverse® RX	U41501H10RX	FDA UDI	Class II	Active
True Dilatation	T214512	FDA UDI	Class II	Active
True Dilatation	0284514	FDA UDI	Class II	Active
GlidePath	5347230	FDA UDI	Class II	Active
Conquest®	CQ5052	FDA UDI	Class II	Active
Rival®	RV8084	FDA UDI	Class II	Unknown
Conquest®	CQ7572	FDA UDI	Class II	Active
Dorado®	DR12054	FDA UDI	Class II	Active
Ultraverse® 035 PTA Dilatation Catheter	U35150312	FDA UDI	Class II	Active
Magnum	MN1613	FDA UDI	Class II	Active

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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.

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.