FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Recall number
- Z-1392-2022
- Recalling firm
- Boston Scientific Corporation
- Product
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Status
- Open, Classified
- Initiated
- 2022-05-31
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software Manufacturing/Software Deployment
- Action
- 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.
- Quantity
- 57
- Distribution
- Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
- Lot, serial or model codes
- UDI-DI (GTIN): 00878953005522 Lot: 27770466
- 510(k) numbers
- ["K062719"]
- PMA numbers
- not on file
- Product code
- GEX
- 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