Aortic Cutter 3.8MM AC-3038Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607567700260), received between Aug 25, 2020 and Sep 1, 2022 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2022Premature Activation; Premature Activation

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTER (3.8MM), AFTER RELEASING THE SAFETY LOCK, IT WAS NOT POSSIBLE TO USE IT BECAUSE IT WAS ACTIVATED JUST BY TOUCHING THE ACTIVATION BUTTON LIGHTLY. THERE WAS NO EFFECT ON THE PATIENT BECAUSE HE WAS WEARING A CAP. SURGERY SUCCESSFULLY COMPLETED USING NEW AC-3038 CUTTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342425 ↗
• MalfunctionJul 15, 2022Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE THE AORTIC CUTTERS, 5-PACK (3.8MM) UNLOCK BUTTON WAS TOO STIFF TO UNLOCK. A NEW AORTIC CUTTER WAS PUT OUT, AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS. THERE IS NO DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15027092 ↗
• MalfunctionNov 12, 2021Mechanical Problem; Mechanical Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12807298 ↗
• MalfunctionNov 8, 2021Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775532 ↗
• MalfunctionOct 9, 2021Premature Activation; Premature Activation

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12602543 ↗
• MalfunctionSep 24, 2021Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTERS (3.8MM). THEY PRESSED THE CUTTER OPERATION BUTTON AFTER RELEASING THE SAFETY LOCK, BUT THE BUTTON WAS HARD AND THE CUTTER DID NOT COME OUT. THERE WAS NO PROBLEM WHEN THEY PREPARED AND USED A SUBSTITUTE CUTTER. IT HAS NO EFFECT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526141 ↗
• MalfunctionApr 30, 2021Mechanical Problem; Mechanical Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTER (3.8MM). WHEN PRESSING THE BUTTON TO UNLOCK AND PULL OUT THE CUTTER, IT WAS NECESSARY TO PRESS HARDER THAN USUAL. THE SKIN WAS NOT PIERCED. THEY PUT OUT THE SAME NEW DEVICE, AND THIS TIME WERE ABLE TO USE IT SAFELY. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752057 ↗
• MalfunctionApr 8, 2021Firing Problem; Firing Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTER (3.8MM). THEY TRIED TO MAKE A HOLE IN AORTA. UNLOCKED IT AND PRESSED THE BUTTON STRONGLY, BUT THE CUTTER DID NOT COME OUT FIRMLY. JUDGING THAT IT WAS A MALFUNCTION. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11636156 ↗
• MalfunctionFeb 4, 2021Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTERS, 5-PACK (3.8MM), THEY FELT THAT THE CAP PART WAS LOOSE FROM THE BEGINNING AND WAS NOT FIRMLY ATTACHED. WHEN PRESSING THE BUTTON TO UNLOCK AND PULL OUT THE CUTTER, IT WAS NECESSARY TO PRESS HARDER THAN USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11279015 ↗
• MalfunctionOct 21, 2020Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AORTIC CUTTERS (3.8MM) WAS NOT SHARP. IT BROKE, BUT IT WASN'T ENOUGH. THE NEW PUNCH WAS USED AGAIN AND THE OPERATION WAS FINISHED. THERE SEEMS TO BE NO PROBLEM WITH THE PATIENT. THE OPERATION HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10711598 ↗
• MalfunctionOct 12, 2020Failure to Cut; Failure to Cut

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, AORTIC CUTTERS (3.8MM) WAS NOT SHARP. THE NEW PUNCH WAS USED AGAIN AND THE OPERATION WAS FINISHED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10667211 ↗
• MalfunctionAug 25, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE USING AORTIC CUTTERS, 5-PACK (3.8MM), AN ABNORMALITY WAS FOUND IN THE NEEDLE. THE NEEDLE BENT ALMOST AT A RIGHT ANGLE, CAUSING AN ABNORMALITY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451575 ↗