Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall involves a medical device with potential for mechanical failure. No illnesses or injuries have been reported, and the hazard is theoretical rather than realized. Per the severity rubric, risk-of-harm products where injury has not yet been reported score at a maximum of 3 (High).
Plain-English summary
Olympus Corporation of the Americas is recalling the LithoCrushV Single Use Mechanical Lithotriptor V (Model BML-V442QR-30), a medical device used in endoscopic procedures to crush gallstones in the bile duct.
The device is being recalled because of the potential for the distal tip to tear during use.
This recall affects 989 units distributed nationwide in the United States. The affected product lots are: 33K-39K, 3XK, 3YK, 3ZK, and 41K-44K. Patients and healthcare providers who have this device should contact Olympus Corporation of the Americas for instructions on product return or disposal.
The recalled product
- 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.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- tip-tearing
- mechanical-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 04953170218422. Model Number: BML-V442QR-30. Lots: 33K-39K
- 3XK
- 3YK
- 3ZK
- 41K-44K
Distribution
Distributed nationwide across the United States.
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