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Single Use Mechanical Lithotriptor V
OLYMPUS MEDICAL SYSTEMS CORP. · Model BML-V237QR-30 · UDI-DI 04953170462597
LQC
Prescription
10
510(k) clearances
2,875
Adverse events (12 deaths)
7
Recalls
22
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-16 | Olympus Corporation of the Americas | Potential for distal tip tearing of the Mechanical Lithotriptor V. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2021-01-04 | Aomori Olympus Co., Ltd. | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
| 2007-09-20 | Olympus America Inc. | Slider knob does not move smoothly causing the user difficulty in advancing the coil sheath |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.