Back to RecallTracker
Health Canada Medical devices

Single Use Mechanical Lithotriptor V

Issued December 31, 2024
Issue
Olympus has identified an increase in complaints for BML-V442QR-30. The complaint data analysis found that distal tip tearing of the Mechanical Lithotriptor V had increased beginning with the production of lot 33k. Olympus has identified 296 complaints for the BML-V442QR-30 globally between June 1, 2021, through July 31, 2024. There were 169 reportable malfunctions, and there was one report of a serious injury in relation to this issue. Recall start date: December 18, 2024
Hazard description
Performance
Product
Product name
Single Use Mechanical Lithotriptor V
Reference
ID
RA-76779