Recall Z-1108-2023 ยท PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
Bard Peripheral Vascular Inc
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.
| Date | Feb 9, 2023 (initiated Dec 22, 2022) |
| Status | Open, Classified |
| Reason | An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 wi |
| Quantity | 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, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.