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.

Other recalls by Bard Peripheral Vascular

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• Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T
  FDA Device · Class II · 2025-12-17 · Bard Peripheral Vascular
• Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation…
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• Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236
  FDA Device · Class I · 2025-03-12 · Bard Peripheral Vascular

All Bard Peripheral Vascular recalls

Source

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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.