ProMax™ Series Bard® C-Max™ Cutting Loop 355321Recalls & reported problems
C. R. Bard, Inc. · ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: ACMI USA Series 28 Fr. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741018596), received between Nov 30, 2018 and Nov 30, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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.
Most reported problems
Device problems
- Break1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2018Break
IT WAS REPORTED THAT THE C-MAX CUTTING LOOP BROKE DURING USE. THERE WAS NO PATIENT INJURY REPORTED. PER FOLLOW UP WITH THE COMPLAINANT BY EMAIL, ON (B)(6) 2018, THE CUTTING LOOP BROKE WHILE INSIDE OF THE PATIENT BUT REMAINED INTACT WHEN REMOVED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8120784 ↗
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- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
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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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