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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 7 of 11

Device	Model / Reference	Registries	Class	Status
Cardioblate Monopolar Pen, 60813, Cardioblate Monopolar Xl, 60814	K070288	FDA 510(k)	Class II	Active
Heparin Dose Response Controls, Model 306-20 Por	K043080	FDA 510(k)	Class II	Active
Generator, Pulse, Demand, Model 5996	K780741	FDA 510(k)	Class III	Active
Model 9408 A Teletrace	K812703	FDA 510(k)	Class II	Active
DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak	K161287	FDA 510(k)	Class II	Active
Medtronic Model 6971	K790074	FDA 510(k)	Class III	Active
Affinity Nt Hollow Fiber Oxygenator With Plasma Resistant Fiber With Carmeda Bioactive Surface, Model Cb511	K000430	FDA 510(k)	Class II	Active
Medtronic Unipolar, Poly Pac Lead-Barr Coat Coils	K913288	FDA 510(k)	Class III	Active
Reveal Plus Insertable Loop Recorder System, Model 9526 Implanted Recorder And Model 6191 Patient Activator	K994331	FDA 510(k)	Class II	Active
6f Taiga Guiding Catheter	K083422	FDA 510(k)	Class II	Active
Medtronic Model 6957	K790429	FDA 510(k)	Class III	Active
6f Z4 Guide Catheter	K042489	FDA 510(k)	Class II	Active
Polyether Urethane Material Change In Neurostimulation Leads	K040568	FDA 510(k)	Class II	Active
Medtronic Model 3888 Pisces-Quad Plus Lead	K923567	FDA 510(k)	Class II	Active
Medtronic Models 3983a And 3983b Resume Leads	K921558	FDA 510(k)	Class II	Active
Export Aspiration Catheter	K023303	FDA 510(k)	Class II	Active
Canmed 102	K844099	FDA 510(k)	Class II	Active
Minimax Oxygenation System	K912655	FDA 510(k)	Class II	Active
Model 6984m Lead Extender Kit	K915724	FDA 510(k)	Class II	Active
Neurological Leads (packaging Modification)	K940416	FDA 510(k)	Class II	Active
Attain Access 6218 Left-Heart Delivery System, Model 6218	K012083	FDA 510(k)	Class II	Active
Medtronic Stylet Kit, Models 6282, 6293, And 6254	K010906	FDA 510(k)	Class II	Active
Maxima Forte Hollow Fiber Oxygenator With Plasma Resistant Fiber	K962641	FDA 510(k)	Class II	Active
Maxima Forte Hardshell Venous Reservoir	K961836	FDA 510(k)	Class II	Active
Model 5866-37m Lead Adaptor Kit	K904575	FDA 510(k)	Class II	Active
Medtronic A2 Clinical Imaging System	K811187	FDA 510(k)	Class I	Active
Complete Se Self Expanding Biliary Stent System	K062264	FDA 510(k)	Class II	Active
Medtronic Model 6405	K853818	FDA 510(k)	Class II	Active
Neuromed Selectra #7720	K812704	FDA 510(k)	Class II	Active
Respond Ii...neuromuscular Stimulator	K813008	FDA 510(k)	Class II	Active
Medtronic Pisces Generation Ii Lead Kit	K800193	FDA 510(k)	Class II	Active
Spinal Cord Stimulation Sys Se-4	K833990	FDA 510(k)	Class II	Active
Medtronic Cardiocare Memorytrace Er Model 4221	K912084	FDA 510(k)	Class II	Active
Model 5311b A-V Pacing System Analyzer	K910595	FDA 510(k)	Class II	Active
Mastergraft Putty Bone Void Filler	K051386	FDA 510(k)	Class II	Active
Medtronic Model 69575	K800944	FDA 510(k)	Class III	Active
Sentrant Introducer Sheath with Hydrophilic Coating	K171866	FDA 510(k)	Class II	Active
Dualscreen	K955291	FDA 510(k)	Class II	Active
Medtronic Model 3991, 3991c, 3992, 3992c, 3993, 3993c, 3994, 3994c Leads Or, Transverse Tripolar Leads Or, Ttl	K952459	FDA 510(k)	Class II	Active
Alternate Sterile Pkg Implantable Pulse Generators	K854482	FDA 510(k)	Class III	Active
Epicardial, Unipolar Lead 4951	K842065	FDA 510(k)	Class II	Active
Ventricular Lead, Model 6959	K790143	FDA 510(k)	Class III	Active
Attain Prevail Left Heart Delivery System Moddel, 6228sys	K032622	FDA 510(k)	Class II	Active
Implantable Pulse Generators	K925106	FDA 510(k)	Class II	Active
Models 6207/6208/6209/6210/6211/6212/6214 (pli's)	K900515	FDA 510(k)	Class II	Active
Pulse Generators, Models 5983, 5989	K790068	FDA 510(k)	Class III	Active
Transvenous Tined Ventricular/Atrial	K842031	FDA 510(k)	Class III	Active
Models 2411/2418 Ventricular-Inhibited	K791093	FDA 510(k)	Class III	Active
Add'l Labeling To Minix Models And Minix St Models	K895495	FDA 510(k)	Class III	Active
Medtronic Model 5866-45 Sizing Sleeve	K890644	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.