The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1108-2023·Announced 2023-02-15

Vascular Covered Stent Recalled Due to Deployment Failure Risk

Bard Peripheral Vascular Inc is recalling approximately 10,815 Covera Vascular Covered Stent devices due to poor slide block bonding that may prevent proper deployment during vascular procedures.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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: FDA Class II recall with no reported deaths, injuries, or hospitalizations. The slide block bonding defect creates a risk-of-harm situation where devices may fail to deploy, preventing intended vascular treatment, qualifying it as 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

The Covera Vascular Covered Stent is a flexible, self-expanding medical device used in vascular procedures. It consists of an ePTFE-covered nitinol stent with a carbon-impregnated inner lumen. Approximately 10,815 devices have been distributed throughout the United States and Canada.

An increase in complaint reports identified a defect in the slide block bonding of affected devices. This defect may prevent the stent from deploying properly during the medical procedure, which could affect the intended treatment outcome.

The affected devices are identified by specific catalog numbers and lot/serial numbers listed in the recall notice. Healthcare providers and patients with these devices should contact Bard Peripheral Vascular Inc for further guidance on device management and potential options.

The recalled product

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.
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Vascular Stent
Hazard
Affected units
10,815

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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