CleanCut Rotating Aortic Punch RCL35Recalls & reported problems
Quest Medical Inc · Class 1
Data updated Oct 16, 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 10634624373508), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 16, 2026.
Most reported problems
Device problems
- Device Operates Differently Than Expected1
- Physical Property Issue1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2017Device Operates Differently Than Expected; Physical Property Issue
THE MANUFACTURER WAS FORWARDED A MEDWATCH REPORT, REFERENCE (B)(4), WHICH ALLEGED AN ISSUE ENCOUNTERED WITH THE AORTIC PUNCH DURING USE. THE REPORT STATED THAT THE PHYSICIAN WAS COMPLETING A CABG AND NOTED THE AORTIC PUNCH "WOULD NOT CUT OR ACTIVATE CUTTING DEVICE." THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE ALLEGED ISSUE. THE AORTIC PUNCH WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. FOLLOW UP ATTEMPTS WITH THE USER FACILITY HAVE NOT YET BEEN ANSWERED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6621327 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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