Recall Z-1392-2022— Boston Scientific Corporation

Name: FDA recall Z-1392-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-31

Class III · Ongoing

Class III FDA medical device recall by Boston Scientific Corporation, initiated 2022-05-31. It names one FDA 510(k) clearance: K062719. Product: GreenLight HPSEA Laser Fibers, UPN 0010-2092. Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class III
Status: Ongoing
Initiated: 2022-05-31
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K062719 — GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIESLaserscope·cleared 2006-12-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GreenLight HPSEA Laser Fibers, UPN 0010-2092

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.