BOA VISION

Richard Wolf GmbH · Model 7355071US · UDI-DI 00814334022825

510(k) clearances

Adverse events (7 deaths)

Recalls

Facilities

Description

SENSOR-URETERORENOSCOPE 8.7FR WL 680MM flexible, working channel 3.6Fr, slanted distal tip Ø 6.6Fr, TL 980mm, deflection +270°/-270°, two function buttons, for connection to ENDOCAM Logic HD, LED-illumination, distal Sensor, Fixfocus

Recalls

Date	Firm	Reason
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.
2024-07-23	Karl Storz Endoscopy	Various medical device product IFUs contain 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.