Medtronic Vascular Recalls Attain Hybrid Guide Wires Due to Coating Defect
Medtronic Vascular is recalling 1,674 Attain Hybrid Guide Wires because the PTFE coating may delaminate and detach from the device.
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 1,674 units of the Attain Hybrid Guide Wire, including models GWR419478, GWR419488, and GWR419688. The recall is due to a potential defect where the polytetrafluoroethylene (PTFE) coating may delaminate and detach from the guidewire.
The affected devices were distributed worldwide, including nationwide in the United States and in numerous other countries. The Attain Hybrid Guide Wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
Healthcare providers and patients should stop using the affected guide wires and contact Medtronic Vascular for further instructions on how to proceed.
The recalled product
- Product
- ATTAIN HYBRID¿ Guide Wire; Models: GWR419478, GWR419488, GWR419688 The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasculature.
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 1,674
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
Same manufacturer · Medtronic Vascular
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Same hazard · material detachment
See all →- SevereBoston Scientific Cardiac Catheters Recalled for Material Delamination
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- SevereExpo 5F Catheters Recalled for Guidewire Advancement Failure
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- SevereExpo 5F Cardiac Catheters Recalled for Polyurethane Delamination and Guidewire Advancement Failure
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