Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-1392-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

GreenLight HPSEA Laser Fibers, UPN 0010-2092

Product Classification:

Class III

Date Initiated: May 31, 2022

Date Posted: July 27, 2022

Recall Number: Z-1392-2022

Event ID: 90458

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.

Status: Ongoing

Product Quantity: 57

Code Information:

UDI-DI (GTIN): 00878953005522 Lot: 27770466

Distribution Pattern:

Domestic distribution to AR CA IL ME MI NC TX Foreign distribution to Australia, Canada, and France.

Voluntary or Mandated:

Voluntary: Firm initiated