GreenLight HPSEA Laser Fibers, UPN 0010-2092 recallZ-1392-2022 · Boston Scientific Corporation · initiated May 31, 2022
Class III Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software Manufacturing/Software Deployment
What the company is doing
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.
Recall details
- Recall number
- Z-1392-2022
- Recall class
- Class III
- Status
- Open, Classified
- Initiated by the company
- May 31, 2022
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 57
- Product code
- GEX
- FDA submissions
- K062719
- Distribution
- Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.
Product description
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 00878953005522 Lot: 27770466
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- GreenLight HPS EA 0010-2092Boston Scientific Corporation · Powered Laser Surgical Instrument1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page