Recalls / —
—#170834
Product
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
- FDA product code
- FGE — Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K965147
- Affected lot / code info
- Lot 22960201
Why it was recalled
The sterile barrier may contain packaging seal defects.
Root cause (FDA determination)
Other
Action the firm took
Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291
Distribution
- Distribution pattern
- The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Timeline
- Recall initiated
- 2018-12-26
- Terminated
- 2020-04-17
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #170834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.