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Open, Classified

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

FDA Recall Z-0757-2021 · 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.

K974541MODIFIED URETERAL INDWELLING CATHETER/STENTBoston Scientific Corp · 1998-02-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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