FDA Medical Device Recalls (openFDA)
Boston Scientific Corp: Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
- Recall number
- Z-1238-06
- Recalling firm
- Boston Scientific Corp
- Product
- Boston Scientific Contour VL Injection Stent with Hydro Plus Coating, 6 FR (2.0 mm) x 22-30 cm (220-300mm), sterile, UPN: M0061856300. Ureteral stent.
- Status
- Terminated
- Initiated
- 2006-05-10
- Posted
- 2006-07-13
- Terminated
- 2006-11-01
- Reason
- Instructions on how to inject are not included in the package.
- Root cause
- Other
- Action
- A letter dated 5/10/06 was sent to each consignee requesting that they discontinue use of, and return, the product.
- Quantity
- 29
- Distribution
- New York and Pennsylvania.
- Lot, serial or model codes
- Lot 8473180.
- 510(k) numbers
- ["K010002"]
- PMA numbers
- not on file
- Product code
- FAD
- Firm FEI
- 1828132
- Firm city
- Spencer
- Firm state
- IN
- 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