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

FDA device recall Z-1108-2023 · posted 2023-02-09 · Open, Classified

Recall details

Recalling firm

Bard Peripheral Vascular Inc

Reason for recall

An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

Action taken

On 12/22/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx and/or email to customers informing them that BD has identified through customer complaints that the Covera" Vascular Covered Stent has the potential to exhibit deployment issues (i.e., failure to deploy the covered stent) due to slide block bond failures in the device handle. Customers are instructed to: 1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. 3. If customers purchased this product from a distributor, contact the distributor for further instructions and replacement, as available, resolution. 4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not customers have any of the product so that BD may acknowledge receipt of this notification and subsequently process replacements, as available, regarding impacted product. 5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. 6. Please contact BD representative if assistance is required with this process or contact the number below for further assistance: North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: productcomplaints@bd.com

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

PFV

Quantity affected

10,815 devices (U.S. total)

Distribution

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM

Date initiated

2022-12-22

Date posted

2023-02-09

Location

Tempe, AZ