Boston Scientific Corporation GreenLight HPSEA Laser Fibers, UPN 0010-2092 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GreenLight HPSEA Laser Fibers, UPN 0010-2092
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
UDI-DI (GTIN): 00878953005522 Lot: 27770466
Products Sold
UDI-DI (GTIN): 00878953005522 Lot: 27770466
Boston Scientific Corporation is recalling GreenLight HPSEA Laser Fibers, UPN 0010-2092 due to Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Lase. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, IL, ME, MI, NC, TX
Page updated: Jan 10, 2026