—#184740

Product

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

FDA product code: FAD — Stent, Ureteral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K974541
Affected 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.

Why it was recalled

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

Root cause (FDA determination)

Process design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern: Distribution US nationwide and Japan.

Timeline

Recall initiated: 2020-11-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184740. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.