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.
Recall
- Recall Number
- Z-1108-2023
- Event Number
- 91359
- Firm
- Bard Peripheral Vascular Inc
- FEI Number
- 2020394
- Product Code
- PFV
- Status
- Open, Classified
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- December 22, 2022
- Posted
- February 9, 2023
- Address
- 1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438
Description
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.
An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.
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: [email protected]
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.
10,815 devices (U.S. total)