FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- Recall number
- Z-0758-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- Contour VL Variable Length Ureteral Stent Set, UPN M006180155090, M006180156090, M006180156180, M006180156190
- Status
- Open, Classified
- Initiated
- 2020-11-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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
- Process design
- 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.
- Quantity
- 458 units
- Distribution
- Distribution US nationwide and Japan.
- Lot, serial or model codes
- GTIN 08714729423768: Lots 25928323, 25928324. GTIN 08714729423829: Lots 25928325, 25928326, 25933063, 25933064, 25933065. GTIN 08714729772743: Lot 25965814. GTIN 08714729765837: Lot 25966020.
- 510(k) numbers
- ["K974541"]
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28