Mallinckrodt Institute G08417Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002084179), received between Apr 27, 2016 and May 4, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 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.

• MalfunctionMay 4, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED AN ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET WAS RETURNED TO THE DISTRIBUTOR DUE TO A HAIR BEING FOUND INSIDE THE PACKAGE TWO WEEKS PRIOR BY QUALITY CONTROL. THE REPORTED FOREIGN MATTER WAS DISCOVERED BEFORE USE; THEREFORE, NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7486098 ↗
• MalfunctionMar 5, 2018Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material; Tear, Rip or Hole in Device Packaging; Device Contamination with Chemical or Other Material

  THE CUSTOMER REPORTED THAT A FOREIGN OBJECT WAS DISCOVERED INSIDE OF THE PACKAGING OF THE ULTRATHANE WILLS-OGLESBY SINGLE LUMEN MALLINCKRODT INST MODIFICATION GASTROSTOMY SET. THE OBJECT REPORTEDLY PUNCTURED THE PACKAGING AS WELL. THE DEVICE DID NOT MAKE CONTACT WITH ANY PATIENT; ACCORDING, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT PROBLEM. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, BUT THE INVESTIGATION IS STILL PENDING AS OF THE DATE OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 7313565 ↗
• MalfunctionFeb 15, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE PATIENT RETURNED HOME AFTER IMPLANTATION OF THE CATHETER, THEY FOUND THAT THE CATHETER AND HUB JUNCTION WERE LEAKING. THE PATIENT RETURNED TO THE HOSPITAL TO HAVE THE CATHETER REPLACED, BUT THERE WERE NO FURTHER INJURIES ASIDE FROM THIS ADDITIONAL PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7273830 ↗
• InjuryApr 27, 2016Material Separation; Material Separation

  THE MALE PATIENT EXPERIENCED DIFFICULTY WHEN HIS G-TUBE WAS NOT WORKING. THE PHYSICIAN PLACED A GUIDE TO DO AN EXCHANGE/OVER THE WIRE, AND NOTED THAT THE TUBE WAS COMPLETELY BROKEN ABOUT 2 INCHES FROM THE DISTAL END OF THE TUBE. THE CATHETER LOOKED LIKE IT HAD EXPLODED, AS IT HAD COMPLETELY SEPARATED WHILE IN THE PATIENT. A RETRIEVAL SET WAS USED TO RETRIEVE THE DISTAL PORTION OF THE CATHETER AND NO HARM WAS REPORTED TO THE PATIENT. ANOTHER G TUBE WAS PLACED.

  Patient problems: No Code Available

  MAUDE report 5612203 ↗