Food, drugs, devices › Boston Scientific Corporation
Device recall: GreenLight HPSEA Laser Fibers, UPN 0010-2092
FDA enforcement event 90458 is a device recall by Boston Scientific Corporation of Marlborough, MA, initiated 31 May 2022 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Boston Scientific Corporation has 162 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Boston Scientific Corporation, Marlborough, MA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1392-2022 | GreenLight HPSEA Laser Fibers, UPN 0010-2092 | 57 | Class III | Ongoing | 27 Jul 2022 |
Context
Other enforcement events for Boston Scientific Corporation
All 162 events for Boston Scientific Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.