Mammotome Revolve EX CA000460001Recalls & reported problems
Devicor Medical Products, Inc. · Revolve EX Ultrasound Probe with Sleeve - System Registered- CE · Class 2
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 00841911102342), received between Mar 6, 2024 and Mar 6, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
InjuryMar 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THEY ENCOUNTERED DENSER TISSUE, AND DOCTORS FELT THE NEEDLE WAS NOT ADVANCING SMOOTHLY. DESPITE CONSIDERABLE EFFORT, IT REMAINED STUCK, CAUSING AN ACCIDENTAL CUT TO THE PATIENT'S SKIN. AFTER THE SURGERY WAS COMPLETED AND THE NURSE APPLIED PRESSURE TO STOP THE BLEEDING, THE WOUND BECAME SMALLER, SO THE DOCTOR ONLY NEEDED TO STITCH IT A FEW TIMES AND THEN FINISHED. PROCEDURE WAS COMPLETED WITH DEVICE.
Patient problems: Laceration(s)
MAUDE report 18847622 ↗
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- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 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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