Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
FDA Recall Z-0758-2021 · Posted None
Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFAD
Date Initiated2020-11-16
Product Quantity458 units
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.
Firm Action
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.
Root Cause
Process design
Distribution Pattern
Distribution US nationwide and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.