Recall Z-1108-2023— Bard Peripheral Vascular Inc
Class II · Ongoing
Class II FDA medical device recall by Bard Peripheral Vascular Inc, initiated 2022-12-22. FDA's recall record names no specific 510(k) clearance for this event. Product: The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.. Reason: An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding..
- Recalling firm
- Bard Peripheral Vascular Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-12-22
- Firm location
- Tempe, AZ, United States
Product description
The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.
Reason for recall
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
Data sourced from openFDA. This site is unofficial and independent of the FDA.