—#211503

Product

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.

FDA product code: LQC — Lithotriptor, Biliary Mechanical
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K

Why it was recalled

Potential for distal tip tearing of the Mechanical Lithotriptor V.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-12-16
Posted by FDA: 2025-01-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #211503. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.