PEG 24 G22635Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002226357), received between Jan 12, 2018 and Jan 12, 2018 — classified as 1 death.

1 other recall cover devices cleared under the same FDA submission (K920703); they may or may not involve this specific model.

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

• DeathJan 12, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG), THE PHYSICIAN USED A COOK PEG 24 PERCUTANEOUS ENDOSCOPIC GASTROSTOMY SET - PUSH. THEY WERE STARTING THE FIRST PORTION OF THE PROCEDURE. THE WIRE GUIDE, WITH THE KIT, WAS GRABBED WITH A SNARE, PULLED UP THROUGH THE MOUTH, AND OUT OF THE ABDOMEN. WHEN PLACING THE PEG TUBE OVER THE WIRE GUIDE, THEY COULD NOT GET THE TUBE TO PASS THROUGH THE ABDOMEN. THERE WAS A KINK IN THE MIDDLE OF THE WIRE GUIDE. THEY COULD NOT COMPLETE THE PROCEDURE AND EVERYTHING WAS REMOVED. ACCORDING TO THE CUSTOMER, THE AREA LOOKED LIKE A WEAK SPOT ON THE WIRE GUIDE. THEY SENT THE PATIENT TO X-RAY AND FOUND HIS ABDOMEN WAS VERY DISTENDED. AIR WAS INFILTRATING THE ABDOMINAL CAVITY. THE PATIENT WENT FOR LAPAROSCOPIC SURGERY AND PASSED AWAY. ADDITIONAL INFORMATION RECEIVED ON 12/18/2017: THE X-RAY REVEALED A PNEUMOPERITONEUM. ADDITIONAL INFORMATION RECEIVED ON 01/12/2018 FROM THE NURSE MANAGER: WE REALLY WERE NOT FILING A ¿COMPLAINT¿, BUT MERELY ENQUIRING IF YOUR COMPANY HAD BEEN EXPERIENCING ANY ISSUES REGARDING THE GUIDE WIRES. I DO NOT BELIEVE THAT WE ARE ATTRIBUTING THE PATIENT DEATH TO YOUR PRODUCT.

  Patient problems: Death; Perforation

  MAUDE report 7187352 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K920703. One submission often covers many models, so check the product and lot details in each record.

• Z-1910-2009 · Jul 24, 2009 · Terminated
  Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide enteral nutrition to patients requiring nutritional supp