GreenLight HPSEA Laser Fiber Recall Due to Card Incompatibility Error
Boston Scientific is recalling GreenLight HPSEA Laser Fibers due to an incompatibility with the fiber card that causes an error message and requires equipment replacement during procedures.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a device compatibility issue that causes operational failure and procedure delays but no reported illness, injury, or safety risk. Class III recalls are typically scored 1-2, and this warrants a 2 due to the operational impact requiring corrective action during procedures.
Plain-English summary
Boston Scientific Corporation is recalling GreenLight HPSEA Laser Fibers (UPN 0010-2092, Lot 27770466). Fifty-seven units from the affected lot were distributed domestically to facilities in Arkansas, California, Illinois, Maine, Michigan, North Carolina, and Texas, with additional units distributed to Australia, Canada, and France.
Users of the affected laser fibers have reported receiving a "Fiber type does not match card type" error message on the GreenLight XPS Laser console. This incompatibility between the laser fiber and fiber card requires replacement of both components during procedures.
The result of this incompatibility is prolonged procedure time while defective equipment is replaced. The FDA has classified this as a Class III recall.
The recalled product
- Product
- GreenLight HPSEA Laser Fibers, UPN 0010-2092
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Surgical Laser
- Affected units
- 57
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI (GTIN): 00878953005522 Lot: 27770466
Distribution
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