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.
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 medical device with a risk of harm (coating detachment) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
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
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