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LithoVue™ Elite
BOSTON SCIENTIFIC CORPORATION · Model M0067940000 · UDI-DI 08714729997337
FGB
Prescription
10
510(k) clearances
6,637
Adverse events (7 deaths)
27
Recalls
119
Facilities
Description
Single-Use Digital Flexible Ureteroscope
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
| 2024-12-19 | Karl Storz Endoscopy | Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. |
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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.