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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 3 of 11

Device	Model / Reference	Registries	Class	Status
Percupass Tunneling Tool Model 3452	K772013	FDA 510(k)	Class I	Active
Minix/Minix St Pulse Generators	K932884	FDA 510(k)	Class III	Active
Pulse Generator, A-V Seq.	K772202	FDA 510(k)	Class III	Active
Medtronic Models 4011 & 4511	K822781	FDA 510(k)	Class III	Active
Modified #3587 Resume Se-4/#3487 Pisces-Quad	K873675	FDA 510(k)	Class II	Active
Pisces #3487 Epidural Lead For Spinal	K831746	FDA 510(k)	Class II	Active
Model 1812 Control Console, Accessoriex	K780952	FDA 510(k)	Class II	Active
Mvr Collapsible Venous Reservoir Bag	K920774	FDA 510(k)	Class II	Active
Medtronic Models 5966/5967, Etc.	K800069	FDA 510(k)	Class III	Active
Model 6495 Bipolar Temporary Myocardial Pacing Lead	K012460	FDA 510(k)	Class II	Active
Tuna System, Models 8909, 8929, 8930, 8934	K052413	FDA 510(k)	Class II	Active
Maxima Plus Hollow Fiber Oxygenator	K941473	FDA 510(k)	Class II	Active
Medtronic Models 6907/6901	K790766	FDA 510(k)	Class III	Active
Medtronic Model 546	K782108	FDA 510(k)	Class II	Active
Cardioblate Dispersive Electrode Adapter (accessory), Model 60884	K043291	FDA 510(k)	Class II	Active
Radiolucent Ecg Electrode Model No: 1680	K890201	FDA 510(k)	Class II	Active
Medtronic Model 9410 Teletrace Receiver	K791778	FDA 510(k)	Class II	Active
Medtronic Classix Models 8436/8437/8438	K871866	FDA 510(k)	Class III	Active
Alternate Package Config. For Implant. Pulse Gen.	K862974	FDA 510(k)	Class III	Active
Model 5866-46 Sleeve Kit	K910568	FDA 510(k)	Class II	Active
Endocardial Pacing Leads-Anchoring Sleeve Modified	K884005	FDA 510(k)	Class III	Active
Epidural Lead - Model 3481	K780001	FDA 510(k)	Class II	Active
7f Sherpa Nx Guide Catheter	K051846	FDA 510(k)	Class II	Active
Bipolar Endocardial Pacing Lead, M. 6902	K780622	FDA 510(k)	Class III	Active
Attain 6216a-Mp Multi-Purpose Guide Catheter For Left-Heart Delivery	K024032	FDA 510(k)	Class II	Active
Unipolar Spectrax Impl. Pulse Generat.	K811350	FDA 510(k)	Class III	Active
Medtronic Temptron	K790261	FDA 510(k)	Class III	Active
Modified Memorytrace Er Model 4221 Ecg Monitor	K915769	FDA 510(k)	Class II	Active
InTRAkit	K162097	FDA 510(k)	Class II	Active
Models 5069/5071 Myocardial Pacing Leads	K902002	FDA 510(k)	Class III	Active
Models 4012/4512 Transvenous Tined-	K842032	FDA 510(k)	Class III	Active
Model 5985 Pacemaker Pulse Generator	K800285	FDA 510(k)	Class III	Active
Modification Of Maxima Forte' Hollow Fiber Oxygenator With Balance Biocompatible Surface With Plasma Resistent Fiber (m0	K984271	FDA 510(k)	Class II	Active
Model 5013 Transvenous Ventricular Pacing Lead	K874792	FDA 510(k)	Class III	Active
Modified Label For/Spectrax Sxt Implant. Pulse Gen	K862071	FDA 510(k)	Class III	Active
Model 6492 Unipolar Temporary Atrial Pacing Lead	K012458	FDA 510(k)	Class II	Active
Unipolar Pediatric Temporary Pacing Lead, #6491	K902342	FDA 510(k)	Class II	Active
Xtrel, Model Number 3425	K883780	FDA 510(k)	Class II	Active
Model 2188 Coronary Sinus Lead.	K961936	FDA 510(k)	Class III	Active
Medtronic Twist Lock Anchor (partnumber 103953/3550tla)	K972906	FDA 510(k)	Class II	Active
Promeon Hydrogel Dressing #45 Sterile W/ Mesh	K915359	FDA 510(k)	Class I	Active
Model 3487a Pisces Epidural Lead	K881491	FDA 510(k)	Class II	Active
Medtronic Model 3991a, 3992a, 3993a, 3994a Leads Or Transverse Tripolar Leads Or Ttl	K964172	FDA 510(k)	Class II	Active
Pacing System Analyzer	K803313	FDA 510(k)	Class II	Active
Neuromuscular Stimulator 3105	K840467	FDA 510(k)	Class II	Active
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor , 3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor, 3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)	K220773	FDA 510(k)	Class II	Active
Transxchange Support Catheter	K033540	FDA 510(k)	Class II	Active
Pacing Lead Model 6991a	K772104	FDA 510(k)	Class III	Active
Medtronic Model 3990 Pns Lead	K925952	FDA 510(k)	Class II	Active
Medtronic Angiographic Guide Wires	K082873	FDA 510(k)	Class II	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.