PILLING IPN056400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 14026704714114), received between Aug 15, 2022 and Jan 3, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Mechanical Jam; Mechanical Jam

  REPORTED ISSUE: DURING USE ON A PATIENT ON (B)(6) 2022 DURING A CORONARY BYPASS, THE PUNCH HAD DIFFICULTY RETURNING TO ITS INITIAL POSITION. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086357 ↗
• InjuryOct 4, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A 51-YEAR-OLD PATIENT WAS TREATED FOR TRANSPLANTATION OF A LEFT KIDNEY INTO THE RIGHT ILIAC FOSSA. DURING THE INTERVENTION, THE PUNCH GOT STUCK IN CLOSED POSITION DURING USE BY THE SURGEON. THE SURGEON HAD TO CUT THE PERIMETER OF THE DEVICE TO RELEASE THE PUNCH FROM THE ILIAC ARTERY. AS A RESULT, THE SUTURE WAS LARGER THAN WHAT IT SHOULD HAVE BEEN. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 15539561 ↗
• MalfunctionAug 15, 2022Entrapment of Device; Entrapment of Device

  THE BLADE DID NOT MAKE A 360 COMPLIANT CUT ON THE ILIAC ARTERY AND AT THE SAME TIME THE UNCUT FLAP GOT STUCK IN THE MECHANISM, WITH THE RISK OF A DISSECTION OF THE ARTERIAL VESSEL NECESSARY TO CARRY OUT THE GRAFT GRAFT OF THE KIDNEY TO BE TRANSPLANTED. THE SAME EVENT WAS REPORTED ON THE CONTRALATERAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223783 ↗
• MalfunctionAug 15, 2022Entrapment of Device; Entrapment of Device

  THE BLADE DID NOT MAKE A 360 COMPLIANT CUT ON THE ILIAC ARTERY AND AT THE SAME TIME THE UNCUT FLAP GOT STUCK IN THE MECHANISM, WITH THE RISK OF A DISSECTION OF THE ARTERIAL VESSEL NECESSARY TO CARRY OUT THE GRAFT OF THE KIDNEY TO BE TRANSPLANTED. THE SAME EVENT WAS REPORTED ON THE CONTRALATERAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223765 ↗