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 Recall Z-0962-2025 · Posted 2025-01-16
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Recalling FirmOlympus Corporation of the Americas
Recall StatusOpen, Classified
Product CodeLQC
Date Initiated2024-12-16
Product Quantity989 units
Reason for Recall
Potential for distal tip tearing of the Mechanical Lithotriptor V.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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