ProMax™ Series Bard® C-Max™ Cutting Loop 355301Recalls & reported problems
C. R. Bard, Inc. · ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: ACMI USA Series 24 Fr. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741018510), received between Jul 27, 2017 and Feb 25, 2019 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (4 reports).
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
- Break4
- Device Damaged Prior to Use1
- Device Dislodged or Dislocated1
- Misassembled1
Patient problems
- No Known Impact Or Consequence To Patient4
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2019Break
IT WAS REPORTED THAT THE CUTTING LOOP BROKE DURING USE. THE COMPLAINANT REPORTED THAT THE CASE WAS CONTINUED AND NOTHING WAS LEFT IN THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8367364 ↗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 NOV 14 2018, THE CUTTING LOOP BROKE WHILE INSIDE OF THE PATIENT BUT THE PIECE WAS REMOVED. THERE WAS NO RESPONSE AS TO WHETHER THE REMOVAL REQUIRED ADDITIONAL SURGERY OR NOT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8120598 ↗MalfunctionAug 24, 2018Misassembled; Device Dislodged or Dislocated; Misassembled
IT WAS REPORTED THAT THE LOOP CAME OUT PAST THE TIP OF THE SCOPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7813922 ↗MalfunctionAug 24, 2018Break
IT WAS REPORTED THAT THE LOOP BROKE WHEN PLACED IN THE SCOPE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7813917 ↗MalfunctionJul 27, 2017Break; Device Damaged Prior to Use
IT WAS REPORTED THAT PRIOR TO USE, THE CUTTING LOOP BROKE.
Patient problems: No Patient Involvement
MAUDE report 6749111 ↗
Other ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL devices
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- Olympus WA22603SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall7 reports
- Olympus WA22621SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall4 reports
- Olympus WA22305SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall3 reports
- Olympus WA22301DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22657SOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 reports
- Olympus WA22305DOLYMPUS Winter & Ibe GmbH · Electrode, Electrosurgical, Active, Urological1 recall2 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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