Agency classClass IOur severity:Severe FDA (Devices)·Z-0266-2014·Announced 2013-11-27

Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk

Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire."

Plain-English summary

Medtronic Vascular is recalling 20 units of COUGAR Steerable Guidewires, including models LVCLS190J, LVCLS190S, LVCXT190J, and LVCXT190S. The recall is due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire.

These medical devices are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature. The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries.

The source text does not specify instructions for consumers or healthcare providers regarding the recall. No illnesses or injuries are reported in the provided text.

The recalled product

Product: COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be…
Manufacturer: Medtronic Vascular
Category: Medical Device — Guidewire
Hazard: coating-delamination
Affected units: 20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

G13A00805 G13A00814 G13A00815 G13A01447 G13A01450 GW547

Distribution

Distributed nationwide across the United States.

The notice also names 45 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Medtronic Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Same manufacturer · Medtronic Vascular

See all →

Severe
Medtronic Angiographic Guidewire Components Shipped Without Required Sterilization
FDA (Devices) · 2021-06-23
Severe
Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
Severe
Medtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
High
Medtronic 6F Launcher Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17
Severe
Medtronic Guide Catheter Recalled for Potential Sterility Compromise
FDA (Devices) · 2021-03-17

Same hazard · coating delamination