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MEDTRONIC VASCULAR, INC.

Last updated September 17, 2026

What MEDTRONIC VASCULAR, INC. makes

The company manufactures non-bioabsorbable soft-tissue mesh anchors, including systems and cassettes for endoscopic or minimally invasive fixation, such as the Heli-FX EndoAnchor System and its thoracic variants. It also produces an introducer sheath with a hydrophilic coating for procedural use.

These devices are regulated under FDA Class II and Class III classifications, with authorisation records in 510(k), PMA, and UDI registries. The company is based in the United States.

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

Frequently asked questions

What types of medical devices does Medtronic Vascular, Inc. primarily manufacture?

Medtronic Vascular, Inc. specializes in non-bioabsorbable soft-tissue mesh anchors designed for endoscopic or minimally invasive surgical fixation. Their portfolio includes systems like the Heli-FX EndoAnchor System and its thoracic-specific variants, as well as ancillary components such as cassettes. Additionally, they produce procedural tools like the Sentrant Introducer Sheath with a hydrophilic coating, which reduces friction during insertion.

Where is Medtronic Vascular, Inc. based, and how does that affect its regulatory oversight?

Medtronic Vascular, Inc. is headquartered in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA classifies these devices as either Class II or Class III, depending on their risk level and intended use, requiring pre-market authorisation through pathways like 510(k) clearances, Premarket Approvals (PMAs), or Unique Device Identification (UDI) registrations.

Which regulatory registries list Medtronic Vascular, Inc.’s devices, and why?

Medtronic Vascular, Inc.’s devices are listed in the FDA’s 510(k), PMA, and UDI registries. The 510(k) pathway applies to Class II devices deemed substantially equivalent to existing approved products, while Class III devices—often higher-risk—require a Premarket Approval (PMA) to demonstrate safety and effectiveness. The UDI registry ensures traceability and transparency in the supply chain, tracking devices throughout their lifecycle for compliance and recall purposes.

How are Medtronic Vascular, Inc.’s devices classified by the FDA, and what does that mean for their use?

The FDA classifies Medtronic Vascular, Inc.’s devices as either Class II or Class III. Class II devices, like some mesh anchors, typically require performance standards and 510(k) clearance to prove they’re as safe and effective as comparable legacy products. Class III devices, such as certain high-risk fixation systems, require a Premarket Approval (PMA) to demonstrate safety and efficacy through rigorous clinical trials, as they lack a predicate device or pose greater risks.

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

Information

Country: US
Address: 3576 Unocal Pl, Santa Rosa, CA, 95403
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3001452571
DUNS Number: 080009661

Catalogue (509)

Page 8 of 11

Device	Model / Reference	Registries	Class	Status
Cardioblate Navigator Tissue Dissection Device	K062727	FDA 510(k)	Class II	Active
Medtronic Octopus Te Stabilizer & Accessories	K041338	FDA 510(k)	Class I	Active
SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System	K170191	FDA 510(k)	Class II	Active
Mds Imager	K801027	FDA 510(k)	N/A	Active
Modification To: Export Catheter	K050139	FDA 510(k)	Class II	Active
Medtronic Intravascular Blood Gas Monitoring	K891013	FDA 510(k)	Class II	Active
Medtronic Model 3550 Accessory Kit (contents) 3550-Ox	K960631	FDA 510(k)	Class II	Active
Attain Prevail Steerable Catheter Set, Model 6228cth	K031211	FDA 510(k)	Class II	Active
Neuromod Stimulator Model 3723	K780186	FDA 510(k)	Class II	Active
Implantable Pulse Devices	K903919	FDA 510(k)	Class III	Active
Medtronic Model 90002065 Mf Tens System	K911963	FDA 510(k)	Class II	Active
Plasma Tfe Vascular Prosthesis Modified Instruc.	K896964	FDA 510(k)	Class II	Active
Medtronic Colvin-Galloway Future Annuloplasty Band, Model 638b	K011395	FDA 510(k)	Class II	Active
Medtronic Model 8436 -pacemaker Pulse Generator	K844957	FDA 510(k)	Class III	Active
Minimax(r)/Maxima(r) Hollow Fiber Oxygenators	K920889	FDA 510(k)	Class II	Active
Plasma Tfe Synthetic Artery-Clarification	K914116	FDA 510(k)	Class II	Active
Transmitter, Model 9406 And 9401	K781986	FDA 510(k)	Class II	Active
Model 6208, 6209, 6210, 6211, 6212, 6214 (pli's)	K890045	FDA 510(k)	Class III	Active
Medtronic Model 4220 Ambulatory Ecg Monitor	K870652	FDA 510(k)	Class II	Active
Medtronic Model 3273/3274 Rf Receiver And Model 3629/3630 Screener	K972043	FDA 510(k)	Class II	Active
Medtronic Extension Passer Tunneling System (38 Cm), Model 3555-38; Medtronic Extension Passer Tunneling System (60 Cm),	K000105	FDA 510(k)	Class II	Active
Medical Safety Cable And Lead System	K912415	FDA 510(k)	Class II	Active
Unipolar Atrial Temporary Pacing Lead, Model 6492	K922182	FDA 510(k)	Class II	Active
Medtronic #6993	K820989	FDA 510(k)	Class III	Active
Myelostat Dorsal Cord Stimulator	K811655	FDA 510(k)	Class II	Active
Canmed 101	K844100	FDA 510(k)	Class II	Active
Caracell	K953118	FDA 510(k)	Class II	Active
Neuromod Comfort Wave #7721 Dual-	K832238	FDA 510(k)	Class II	Active
Implantable Tined, Trans. Pacing Lead/Revis. Label	K871333	FDA 510(k)	Class III	Active
Medtronic Model 6972	K790462	FDA 510(k)	Class III	Active
Tubing And Connectors With Trillium Biopassive Surface	K012538	FDA 510(k)	Class II	Active
Pioneer Plus Catheter, Model Plus 120	K101777	FDA 510(k)	Class II	Active
Modified Unipolar Implant. Pacing Leads W/Is-1	K900984	FDA 510(k)	Class III	Active
Model 6615 Floscan Doppler Diagnostic Catheter	K862673	FDA 510(k)	Class II	Active
Medtronic Model 6958	K800870	FDA 510(k)	Class III	Active
Medtronic Enertrax Model 7100	K822147	FDA 510(k)	Class III	Active
Programmer, Medtronic Model 5984/5985	K791181	FDA 510(k)	Class III	Active
Medtronic Model 8501 Access Port	K861498	FDA 510(k)	Class II	Active
Models 8420 Thru 8423 Pacemaker Gener	K810734	FDA 510(k)	Class III	Active
Modofication To Afffinity 38 Micro Arterial Blood Filter With Carmeda Bioactive Surface, Models Cb351/Cb352	K000379	FDA 510(k)	Class II	Active
Minix, Minix St, New Ic: L74	K902134	FDA 510(k)	Class III	Active
Models 6917t, 6917at & 4951m Epicardial Pace Leads	K921124	FDA 510(k)	Class III	Active
Model 9300 Trend Analyzing Bio-Monitor Sys	K844252	FDA 510(k)	Class II	Active
Medtronic Model 6550 Adjustable Hemostasis Valve	K874117	FDA 510(k)	Class II	Active
Cardioblate Gemini Surgical Ablation Device, Models 49260 And 49261	K070311	FDA 510(k)	Class II	Active
Affinity 20 Micron Arterial Blood Filter With Carmeda Bioactive Surface, Models Cb353/Cb354	K001138	FDA 510(k)	Class II	Active
Medtronic Spinal Cord Stimulation And Peripheral Nerve Stimulation Systems For Pain Relief	K011584	FDA 510(k)	Class II	Active
Medtronic Model 3998 Lead	K971756	FDA 510(k)	Class II	Active
Model Nos. 7495 And 501826 Extensions	K954886	FDA 510(k)	Class II	Active
Medtronic Model 4558m	K940703	FDA 510(k)	Class III	Active

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Authorised Representatives

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Authorities

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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.

Medtronic Vascular, Inc. has 234 recall records spanning from June 8, 2004, to March 23, 2022, with statuses recorded as open, classified, or terminated. The reasons cited include mechanical failures such as detachment of spindle components, radiopaque marker bonds, or taper tips during stent graft deployment; labeling errors such as incorrect usable lengths, master labels, and stentstop assemblies; sterility concerns due to compromised package integrity; and manufacturing defects like retained manufacturing materials in embolization systems. Some records reference procedural complications, such as difficulty flushing delivery systems or potential endoleaks and stent fractures.

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
Mar 23, 2022	Z-1043-2022	—	open, classified	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Mar 23, 2022	Z-1042-2022	—	open, classified	Packaging for Balloon Catheters may be damaged resulting in loss of sterility.
Dec 21, 2021	Z-0657-2022	—	open, classified	Stent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system. Detachment of the taper tip during the implant procedure may lead to a secondary intervention to attempt to remove the taper tip, either by endovascular retrieval or surgical conversion. There is also potential that the taper tip is intentionally left behind in the patient, at the physician's discretion, if not easily removable.
Oct 15, 2021	Z-0291-2022	—	open, classified	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Oct 15, 2021	Z-0292-2022	—	open, classified	Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.
Oct 15, 2021	Z-0290-2022	—	open, classified	During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
Jun 7, 2021	Z-2135-2021	—	open, classified	During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
Jun 7, 2021	Z-2136-2021	—	open, classified	During product complaint investigation, it was determined that during stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.
May 4, 2021	Z-1860-2021	—	terminated	The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.
Apr 28, 2021	Z-1976-2021	—	terminated	Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device. Correct stentstop assembly is 20fr.
Feb 12, 2021	Z-1201-2021	—	open, classified	Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.
Jan 15, 2021	Z-1248-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1245-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1246-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Jan 15, 2021	Z-1247-2021	—	terminated	Sterility may be compromised due to an unsealed pouch
Aug 25, 2020	Z-0088-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Aug 25, 2020	Z-0087-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Aug 25, 2020	Z-0089-2021	—	terminated	Subsequent failure of catheters in the field and failed quality testing
Mar 15, 2019	Z-2605-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2644-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2651-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2749-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2698-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2699-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2732-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2643-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2579-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2574-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2709-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2589-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2575-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2674-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2591-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2604-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2603-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2738-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2562-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2750-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2686-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2688-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2621-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2684-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2721-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2744-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2682-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2733-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2656-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2662-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2647-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2630-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2565-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2654-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2649-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2571-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2635-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2576-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2626-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2692-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2611-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2714-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2633-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2578-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2600-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2618-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2583-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2636-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2752-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2596-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2581-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2726-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2632-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2672-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2593-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2568-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2685-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2652-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2671-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2639-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2585-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2680-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2638-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2710-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2719-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2646-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2718-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2564-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2742-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2594-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2664-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2715-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2717-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2736-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2658-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2650-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2592-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2569-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2597-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2634-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2712-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Mar 15, 2019	Z-2747-2019	—	terminated	There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.