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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
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 used
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Guidewire
- Hazard
- 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
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 →Related recalls
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