PerfectCut Rotating Aortic Punch RCB40Recalls & reported problems
Quest Medical Inc · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10634624324005), received between Dec 2, 2022 and Jan 17, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Jam” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Jam1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Perforation of Vessels1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 17, 2025Mechanical Problem; Mechanical Problem
IT WAS REPORTED TO QUEST MEDICAL. INC. THAT THE DEVICE ALLEGEDLY MALFUNCTIONED AND UNINTENTIONALLY TORE THE SUBCLAVIAN ARTERY DURING THE PROCEDURE. A SIMILAR DEVICE FROM THE SAME LOT WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.
Patient problems: Perforation of Vessels
MAUDE report 21185542 ↗MalfunctionDec 2, 2022Mechanical Jam; Mechanical Jam
IT WAS REPORTED TO QUEST MEDICAL BY THE UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES OF AN ALLEGED ISSUE WITH THE AORTIC PUNCH. ALLEGEDLY, THE PUNCH HAS SEVERAL OCCURENCES WHERE IT GOT STUCK DURING USE AND WOULD NOT RELEASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15911387 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.