LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
This recall is currently active, issued January 16, 2025. It was issued by Olympus Corporation Of The Americas.
- Recall Initiated
- December 16, 2024
- Posted
- January 16, 2025
- Recall Number
- Z-0962-2025
- Quantity
- 989 units
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Distribution
US Nationwide distribution.
Lot / Code Info
UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K
Root Cause
Under Investigation by firm
Action Taken
Olympus notified consignees on 12/16/2024, via URGENT: MEDICAL DEVICE REMOVAL letter. Consignees were instructed to examine inventory for affected devices, cease usage of affected devices, and arrange for return of any affected devices. Consignees were also instructed to acknowledge receipt of the letter through Olympus online portal as well as to notify customers if the affected devices were further distributed.