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LithoVue

BOSTON SCIENTIFIC CORPORATION · Model M006791100Z0 · UDI-DI 08714729891840

FGB Prescription
10
510(k) clearances
6,977
Adverse events (7 deaths)
28
Recalls
119
Facilities

Description

System Workstation

Recalls

DateFirmReason
2026-07-22Boston Scientific CorporationA subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail elect
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-12-19Karl Storz EndoscopyScope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

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Data 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.