FDA Device recall Z-1108-2023

The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework

• FDA Device
• Class II
• ongoing
• Published 2023-02-15

On 2023-02-15 the FDA classified a Class II recall of The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework by Bard Peripheral Vascular, citing an increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

Read the official FDA Device notice

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.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1108-2023%22

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