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CleanCut Rotating Aortic Punch RCL40Recalls & reported problems

Quest Medical Inc · Aortic Punches are used to create a uniform opening in blood vessels during cardiovascular surgery. The vessel graft is inserted into the created opening and sutured to the vessel wall. Aortic Lancets are used to make a small uniform cut in a blood vessel to facilitate insertion of an aortic punch. Punches come in various lengths, diameters and tip configurations. · Class 1

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 10634624374000), received between Jun 8, 2021 and Jun 8, 2021 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Mechanical Jam1

Patient problems

  • Vascular Dissection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 8, 2021Mechanical Jam; Mechanical Jam

    IT WAS REPORTED TO QUEST MEDICAL BY (B)(6) HEALTH THAT, DURING THE USE OF AN RCL40 AORTIC PUNCH, THE PUNCH GOT STUCK, CAUSING A TEAR TO THE AORTA. THE SURGEON HAD TO REPAIR THE HOLE WITH A PERICARDIAL PATCH.

    Patient problems: Vascular Dissection

    MAUDE report 11962830 ↗

Other Instruments, Surgical, Cardiovascular devices

All Instruments, Surgical, Cardiovascular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.