ProMax™ Series Bard® C-Max™ Cutting Loop 355305Recalls & reported problems
C. R. Bard, Inc. · ProMax™ Series Bard® C-Max™ Cutting Loop, Resectoscope Compatibility: Storz Single Stem 24 Fr. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741018541), received between Jun 16, 2022 and Mar 9, 2023 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Intermittent Loss of Power” (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
- Intermittent Loss of Power4
- Overheating of Device2
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE CUTTING LOOP BURNT OFF BOTH ENDS AND DAMAGED THE SCOPE. AS PER NOTIFICATION FROM INVESTIGATOR ON 15FEB2023, IT WAS STATED THAT THE CUSTOMER RETURNED 2 SAMPLES BACK FOR EVALUATION (BATCH# NGGX0669), (BATCH# UNK).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511821 ↗MalfunctionFeb 17, 2023Device Damaged by Another Device; Device Damaged by Another Device
IT WAS REPORTED THAT THE TIP WAS NOT FIRING CORRECTLY IN THE CUTTING LOOP AND THAT THE ISSUE CAUSED SCOPE DAMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16396935 ↗MalfunctionFeb 16, 2023Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE CUTTING LOOP BURNT OFF BOTH ENDS AND DAMAGED THE SCOPE. PER NOTIFICATION FROM INVESTIGATOR ON 15-FEB-2023, ADDITIONAL CUTTING LOOP WAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16385292 ↗MalfunctionJun 20, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUTTING LOOP DID NOT SLIDE WELL IN THE INSTRUMENT AS IT WAS DESIGNED TO. THERE WERE ALSO CONCERNS THAT THE CUTTING LOOP WAS NOT CAUTERIZING AS WELL AS IT SHOULD BE. THIS HAS BEEN HAPPENING WITH DIFFERENT LOT NUMBERS AS WELL. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, CUSTOMER PROVIDED SOME OF THE LOT NUMBERS WITH SIMILAR ISSUES OF CUTTING LOOP NOT SLIDING WELL, AND SIMILAR ISSUES OF CUTTING LOOP NOT CAUTERIZING AS WELL AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14742819 ↗MalfunctionJun 17, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUTTING LOOP DID NOT SLIDE WELL IN THE INSTRUMENT AS IT WAS DESIGNED TO. THERE WERE ALSO CONCERNS THAT THE CUTTING LOOP WAS NOT CAUTERIZING AS WELL AS IT SHOULD BE. THIS HAS BEEN HAPPENING WITH DIFFERENT LOT NUMBERS AS WELL. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, CUSTOMER PROVIDED SOME OF THE LOT NUMBERS WITH SIMILAR ISSUES OF CUTTING LOOP NOT SLIDING WELL, AND SIMILAR ISSUES OF CUTTING LOOP NOT CAUTERIZING AS WELL AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14733825 ↗MalfunctionJun 17, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUTTING LOOP DID NOT SLIDE WELL IN THE INSTRUMENT AS IT WAS DESIGNED TO. THERE WERE ALSO CONCERNS THAT THE CUTTING LOOP WAS NOT CAUTERIZING AS WELL AS IT SHOULD BE. THIS HAS BEEN HAPPENING WITH DIFFERENT LOT NUMBERS AS WELL. PER FOLLOW-UP INFORMATION RECEIVED ON 08-FEB-2022, CUSTOMER PROVIDED SOME OF THE LOT NUMBERS WITH SIMILAR ISSUES OF CUTTING LOOP NOT SLIDING WELL, AND SIMILAR ISSUES OF CUTTING LOOP NOT CAUTERIZING AS WELL AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14732930 ↗MalfunctionJun 16, 2022Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THE CUTTING LOOP DID NOT SLIDE WELL IN THE INSTRUMENT AS IT WAS DESIGNED TO. THERE WERE ALSO CONCERNS THAT THE CUTTING LOOP WAS NOT CAUTERIZING AS WELL AS IT SHOULD BE. THIS HAS BEEN HAPPENING WITH DIFFERENT LOT NUMBERS AS WELL. PER FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2022, CUSTOMER PROVIDED SOME OF THE LOT NUMBERS WITH SIMILAR ISSUES OF CUTTING LOOP NOT SLIDING WELL, AND SIMILAR ISSUES OF CUTTING LOOP NOT CAUTERIZING AS WELL AS IT SHOULD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14711667 ↗
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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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