Contour VL recallZ-0757-2021 · Boston Scientific Corporation · initiated Nov 16, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-0757-2021
- Status
- Open, Classified
- Initiated by the company
- Nov 16, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 458 units
- Product code
- FAD
- FDA submissions
- K974541
- Distribution
- Distribution US nationwide and Japan.
Product description
Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570
Code information (models, lots, serial numbers)
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.
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Contour VL™ M0061801560Boston Scientific Corporation · STENT, URETERAL1 recall45 reports
- Contour VL™ M0061801550Boston Scientific Corporation · STENT, URETERAL1 recall17 reports
- Contour VL™ M0061801570Boston Scientific Corporation · STENT, URETERAL1 recall4 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 86880).
- Z-0758-2021 · Open, ClassifiedContour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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