Recall Z-0962-2025 ยท LQC Lithotriptor, Biliary Mechanical
Olympus Corporation of the Americas
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.
| Date | Jan 16, 2025 (initiated Dec 16, 2024) |
| Status | Open, Classified |
| Reason | Potential for distal tip tearing of the Mechanical Lithotriptor V. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | 989 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.