LithoVue Empower™ M0067919900Recalls & reported problems
Boston Scientific Corporation · Retrieval Deployment Device · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729977612), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT PERTAINS TO A LITHOVUE FLEXSCOPE, LITHOVUE EMPOWER, AND ZERO TIP BASKETS USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION, THROUGH A POST MARKET CLINICAL FOLLOW UP (PMCF) OF RETROSPECTIVE DATA COLLECTION, THAT A LITHOVUE FLEXSCOPE ALONG WITH A LITHOVUE EMPOWER WERE USED DURING A CYSTOURETHROSCOPY WITH LEFT URETERAL STENT PLACEMENT, LEFT RETROGRADE PYELOGRAM WITH FLUOROSCOPIC INTERPRETATION, LEFT URETEROSCOPY WITH STONE EXTRACTION WITHOUT LASER, RIGHT URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. DURING PROCEDURE, IT WAS NOTED A FOCAL TEAR IN THE MUCOSA OF THE DISTAL/MID URETER.
Patient problems: Laceration(s)
MAUDE report 15152314 ↗
Other Adaptor, Bulbs, Miscellaneous, For Endoscope devices
- NA M0067201010Boston Scientific Corporation · Adaptor, bulbs, miscellaneous, for endoscope14 reports
- NA M0067201000Boston Scientific Corporation · Adaptor, bulbs, miscellaneous, for endoscope6 reports
- CLEANASCOPE Sterile Tray Liner SystemCantel Medical (Italy) Srl · Adaptor, bulbs, miscellaneous, for endoscope2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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