GreenLight HPSEA Laser Fibers, UPN 0010-2092
This recall is currently active, issued May 31, 2022. It was issued by Boston Scientific Corporation.
- Company
- Boston Scientific Corporation
- Recall Initiated
- May 31, 2022
- Recall Number
- Z-1392-2022
- Quantity
- 57
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.
Distribution
Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Lot / Code Info
UDI-DI (GTIN): 00878953005522 Lot: 27770466
Root Cause
Software Manufacturing/Software Deployment
Action Taken
On May 31, 2022, the firm distributed Urgent Medical Device Product Removal letters to affected customers. Customers were instructed to immediately segregate and return the product to Boston Scientific.