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U.S. Department of Health and Human Services

Class 2 Device Recall LithoCrushV

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 Class 2 Device Recall LithoCrushVsee related information
Date Initiated by FirmDecember 16, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0962-2025
Recall Event ID 95907
Product Classification Lithotriptor, biliary mechanical - Product Code LQC
ProductLithoCrushV 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.
Code Information UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K, 3XK, 3YK, 3ZK, 41K-44K
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall		Potential for distal tip tearing of the Mechanical Lithotriptor V.
FDA Determined
Cause 2		Under Investigation by firm
ActionOlympus 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 in Commerce989 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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