PILLING IPN915271Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704697950), received between Nov 4, 2021 and Nov 9, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2023Failure to Disconnect; Failure to Disconnect

  IT WAS REPORTED THAT THE DEVICE "WOULD NOT RELEASE THE ARTERY SO SURGEON HAD TO INTERVENE WITH A SCISSORS TO RELEASE THE PRODUCT FROM THE ARTERY". NO REPORT OF PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18104144 ↗
• MalfunctionAug 31, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT "IN THE PACKAGING THERE IS A DP-40K PUNCH WHEREAS THE LABEL INDICATES THE REFERENCE DP-44K. WE ONLY HAVE ONE UNIT IN STOCK FOR WHICH WE ARE EXPERIENCING THIS PROBLEM. THE OTHER UNITS IN STOCK ARE CORRECT". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17663259 ↗
• InjuryDec 15, 2021Difficult to Remove; Difficult to Remove

  HERE IS THE EMAIL FROM THE CUSTOMER EXPLAINING WHAT HAPPENED: I WAS DOING A KIDNEY TRANSPLANT WITH THE DOCTOR ON (B)(6) 2021. HE ASKED FOR A 4.4 AORTIC PUNCH WHICH WAS PROVIDED FROM THE BIN. THE PUNCH GOT STUCK CLOSED ON THE ARTERY DURING SURGERY. THE DOCTOR WAS UPSET AND ASKED THAT YOU TAKE THESE OFF THE SHELF/HAVE THEM LOOKED AT AS THEY DAMAGED THE ARTERY ON THE TRANSPLANT KIDNEY. UPDATE: THE PATIENT'S CONDITION IS OK. THE SURGICAL INTERVENTION PERFORMED WAS ARTERIOTOMY REFASHIONED AND ANASTOMOSIS DONE. ONLY ONE (1) DEVICE WAS USED ON THE PATIENT.

  Patient problems: Perforation of Vessels

  MAUDE report 13009920 ↗
• MalfunctionNov 4, 2021Mechanical Jam; Mechanical Jam

  NOTE: THIS REPORT REPRESENTS OTHER CUSTOMER DEVICE REPORTS WITH UNKNOWN DETAILS BUT REPORTED AS A SIMILAR EVENT TO THE REPORT BELOW. WHILE USE IN A CABG CASE, THE SURGEON WAS USING THE AORTIC PUNCH AND THE INSTRUMENT WAS SLIGHTLY JAMMED/STUCK ON THE TISSUE OF THE AORTA WHEN CLOSED. THE SURGEON WAS ABLE TO DISLODGE AND OPEN THEN PUNCH WITH NO HARM, BUT WAS CONCERNED ABOUT ITS STRUCTURE FOR FUTURE USE. IT HAS NOT HAPPENED IN THE LAST 2 MONTHS AND MAY HAVE BEEN A CERTAIN BOX THAT WAS HAVING THIS ISSUE. THEY DID NOT HAVE THE CORRECT LOT FOR THESE AORTIC PUNCHES USED. THEY ALSO TOLD ME THEY CHECK AND TRY THE PUNCHES PRIOR TO USE IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753916 ↗
• MalfunctionNov 4, 2021Mechanical Jam; Mechanical Jam

  WHILE USE IN A CABG CASE THE SURGEON WAS USING THE AORTIC PUNCH AND THE INSTRUMENT WAS SLIGHTLY JAMMED/STUCK ON THE TISSUE OF THE AORTA WHEN CLOSED. THE SURGEON WAS ABLE TO DISLODGE AND OPEN THEN PUNCH WITH NO HARM BUT WAS CONCERNED ABOUT ITS STRUCTURE FOR FUTURE USE. IT HAS NOT HAPPENED IN THE LAST 2 MONTHS AND MAY HAVE BEEN A CERTAIN BOX THAT WAS HAVING THIS ISSUE. THEY DID NOT HAVE THE CORRECT LOT FOR THESE AORTIC PUNCHES USED. THEY ALSO TOLD ME THEY CHECK AND TRY THE PUNCHES PRIOR TO USE IN A CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12753858 ↗