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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 4 of 11

Device	Model / Reference	Registries	Class	Status
Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead	K973360	FDA 510(k)	Class II	Active
Model 1730 Neotrode With Attached Leadwire	K901555	FDA 510(k)	Class II	Active
Medtronic Model 4058 Pacing Lead	K883743	FDA 510(k)	Class III	Active
Eclipse+, Model Number 7723	K865048	FDA 510(k)	Class II	Active
Processing System, A2 Image	K782047	FDA 510(k)	Class I	Active
U-Clip Device, Model Nc65	K062057	FDA 510(k)	Class II	Active
Minimax (tm) Hardshell Venous Res W/Inte Card Filt	K911789	FDA 510(k)	Class II	Active
Attain Select 6238tel Guide Catheter Set For Left-Heart Delivery	K042194	FDA 510(k)	Class II	Active
Subcupass Tunneling Tool	K780579	FDA 510(k)	Class I	Active
Medtronic #4951	K812599	FDA 510(k)	Class III	Active
Medtronic Model 9455 Teletrace Iii Ecg Monit Syst	K914974	FDA 510(k)	Class II	Active
Model 5866-34 Lead Adaptor Kit	K900627	FDA 510(k)	Class II	Active
Blood Flowmeter System	K780302	FDA 510(k)	Class II	Active
Generators, Atrial Inhibited Pulse	K780327	FDA 510(k)	Class III	Active
Madtronic Dlp Arterial Cannulae	K991066	FDA 510(k)	Class II	Active
Multi-Programmable Pacemaker & Progrmr.	K801584	FDA 510(k)	Class III	Active
Medtronic Arterial Filter	K926413	FDA 510(k)	Class II	Active
Heli-FX EndoAnchor System	K182957	FDA 510(k)	Class II	Active
10600 Deflectable Catheter System, Model 10600	K013517	FDA 510(k)	Class II	Active
Peripheral Nerve Stimulation	K982902	FDA 510(k)	Class II	Active
Neurological Screening Stimulator M 3623	K780758	FDA 510(k)	Class II	Active
Minix 8340, 8341, 8342 Minix-St 8330, 8331	K884215	FDA 510(k)	Class III	Active
Alternate Size E-Z-Pace Electrode	K862298	FDA 510(k)	Class II	Active
Medtronic Model 7499 Extension	K000445	FDA 510(k)	Class II	Active
Medtronic Catheter Access Port Model 8500	K873735	FDA 510(k)	Class II	Active
Modumed Mugx	K780368	FDA 510(k)	Class II	Active
Medtronic 3625 Screener System	K913442	FDA 510(k)	Class II	Active
Promeon Hydrogel Dressing #45 Nonsterile W/ Mesh	K915358	FDA 510(k)	Class I	Active
Transvenous, Permanent Tined Target Tip Pacing Leads/Transvenous, Permanent Screw-In Pacing Leads	K961679	FDA 510(k)	Class III	Active
Pulse Generators, Models 5972/5973	K780061	FDA 510(k)	Class III	Active
Medtronic #3798 Electrode	K812418	FDA 510(k)	Class II	Active
Medtronic Model 4016 Bipolar Endocardial Screw-In	K850968	FDA 510(k)	Class II	Active
Precision Plus Tuna Office System; Presision Tuna Office System; Provu Tuna System	K021804	FDA 510(k)	Class II	Active
Medtens(tm), Model Number 7725	K871722	FDA 510(k)	Class II	Active
Spherical Tip Coronary Ostial Cannula, Model 30011	K034058	FDA 510(k)	Class II	Active
Gt2 Fusion Guide Wire, Model Ntlhlj180, Ntlhls180, Ntlhlj300, Ntlhls300	K001969	FDA 510(k)	Class II	Active
Mod Target/Tips # 4011, 4012, 4511, 4512, 6912, 4016	K854582	FDA 510(k)	Class III	Active
Medtronic Model 6404	K851948	FDA 510(k)	Class II	Active
Medtronic Models 8432/8433/8434 - Pacemaker Pulse	K844958	FDA 510(k)	Class III	Active
Model 6971 W/ Dbs Wire	K790988	FDA 510(k)	Class III	Active
Medtronic Model 5407s, 5807s & 5410s Surg Cables	K914460	FDA 510(k)	Class II	Active
Respond Quadriflex #3129 Single Channel	K823279	FDA 510(k)	Class II	Active
Temporary Screening Lead/ Catheter Kit	K934939	FDA 510(k)	Class II	Active
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter	K230156	FDA 510(k)	Class II	Active
Medtronic A-V Pacing System Analyzer	K812262	FDA 510(k)	Class II	Active
Cardioblate Surgical Ablation Pen, Model 60811c; Cardioblate Surgical Ablation Generator, Model 60880	K013392	FDA 510(k)	Class II	Active
Attain Lds 6216a Left-Heart Delivery System, Model 6216a	K021587	FDA 510(k)	Class II	Active
Modified Medtronic Classix Model 8438 Pulse Gene.	K901535	FDA 510(k)	Class III	Active
Model 2331t Patient Programmer	K880738	FDA 510(k)	Class III	Active
Medtronic Model 2409	K812580	FDA 510(k)	Class III	Active

Related Companies

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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.