Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
- Company
- Boston Scientific Corporation
- Recall Initiated
- November 16, 2020
- Recall Number
- Z-0757-2021
- Quantity
- 458 units
- Firm Location
- Marlborough, MA
Reason for Recall
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
Distribution
Distribution US nationwide and Japan.
Lot / Code Info
GTIN 08714729058410: Lots 25578577, 25598812, 25609220, 25614542, 25614545, 25619687, 25641771, 25713852, 25753933, 25790349. GTIN 08714729067986: Lots 25640715, 25670518, 25686790, 25686791, 25686792, 25741763, 25741770, 25753937, 25790351, 25795704, 25802759, 25809481, 25822104. GTIN 08714729068020: Lots 25578740, 25583824.
Root Cause
Process design
Action Taken
On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.