Covidien 8884715148ERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521661639), received between Nov 4, 2021 and Jul 10, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2025Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE PATIENT WHO WAS IN THE PEDIATRIC ICU HAD A GASTRONOMY TUBE PLACED ON (B)(6) 2025, AND ON (B)(6) 2025 THE BALLOON OF THE TUBE WAS BROKEN, AND GASTRIC CONTENTS WERE COMING OUT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475811 ↗
• MalfunctionJul 2, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT AS IT WAS TIME TO ADMINISTER BEDTIME MEDICATIONS, WRITER ADMINISTERED RESIDENT'S MEDICATION THROUGH THE PEG TUBE AS REQUIRED. RESIDENT WAS UNSETTLED TOWARDS THE END AND WRITER DISCOVERED THAT THE PEG TUBE HAS BEEN DISLODGED FROM ITS PLACE. MULTIPLE ATTEMPTS TO RE-INSERT A NEW PEG TUBE BUT UNSUCCESSFUL. MD ON CALL NOTIFIED AND GAVE AN ORDER TO START NACL 0.9 % AT 75 ML/HOUR IF OTHERS ARE UNABLE TO RE-INSERT THE PEG TUB. RN FROM ANOTHER UNIT ALSO TRIED BUT UNSUCCESSFUL. SO HDC INITIATED WITH NACL AT THE ABOVE RATE AS PER MD ORDER. THE CUSTOMER STATED NO APPARENT HARM. THIS DID REQUIRE TUBE REPLACEMENT AND EXCHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22387544 ↗
• MalfunctionMay 23, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT A TUBE BALLOON WAS TESTED PRIOR TO INSERTION. THE DOCTOR INSERTED THE GASTROSTOMY TUBE WHICH CAME OUT IMMEDIATELY AFTER INSERTION. IT WAS VALIDATED AND A BROKEN BALLOON WAS FOUND. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19382397 ↗
• MalfunctionApr 10, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT WITHIN A MONTH OF INSERTION, THE BALLOON VOLUME OF THE 14FR GASTROSTOMY TUBE DECREASED FROM 5ML TO 2.5ML. THIS WAS REPLACED WITH ANOTHER CARDINAL GASTROSTOMY TUBE. THERE WAS NO FURTHER MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19078632 ↗
• MalfunctionDec 21, 2023Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE TUBE WAS DEFLATED AND DISLODGED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO DELAY IN THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18375046 ↗
• MalfunctionJun 15, 2023Break; Break

  THE CUSTOMER REPORTED THEY WERE UNABLE TO DISCONNECT FROM THE PORT. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2023. THEY HAD TO REPLACE THE TUBES TO RESOLVE THE ISSUE. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2023. THEY COULD NOT UNSCREW THE TUBING FROM THE PORT. THE TUBE REMAINED INTACT HOWEVER AFTER USING SEVERAL TOOLS TO HOLD THE TUBING, THE TUBING BROKE OFF INSIDE THE GASTROSTOMY PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135019 ↗
• MalfunctionJun 2, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE PRODUCT BROKE BELOW THE CONNECTION SITE. THERE WAS NO PATIENT INJURY. PER ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6), 2023, A PORTION OF THE Y-PORT BROKE OFF/FULLY DETACHED. THE TUBE WAS REPLACED TO RESOLVE THE ISSUE. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON (B)(6) 2023, THE PIECE WAS COMPLETELY DETACHED AND WAS MOVING FREELY IN/OUT, LEAKING. THE STAFF WAS UNABLE TO UNSCREW THE FORMULA TUBING FROM THE PORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17050639 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PRODUCT CONTINUES TO BREAK BELOW THE CONNECTION SITE AND UNABLE TO DISCONNECT FROM THE PORT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PURPLE PORT BROKE OFF. PER CUSTOMER, THERE WAS A LEAK WHEN IT BROKE OFF AND THERE WAS NO LEAK WHEN UNABLE TO DISCONNECT FROM THE PORT. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042477 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT BECAUSE OF THE OVERHANG IN A NEW FEEDING SYSTEM, IT IS SCREWED DOWN VERY TIGHTLY AND IS ALMOST IMPOSSIBLE TO LOOSEN. THE KOCHER IS TRIED AND THEREFORE QUICK BREAKAGE OF THE PIECE. NO INJURIES OCCURRED. PER ADDITIONAL INFORMATION PROVIDED ON 30-JUN-2022, WHEN CHANGING THE FEED LINE, THEY DON'T GET THE SCREW CAP OPEN, SO THEY HAVE TO PUT FORCE ON IT AND USE KOCHER FORCEPS TO TRY TO LOOSEN IT. HOWEVER, THIS DOESN'T WORK AND A CRACK APPEARS IN THE Y PART OF THE Y-PORT CAUSING A LEAK. THEY USE POWDERED MILK WHICH GOES THROUGH THE FEED LINE, THEY THEMSELVES THINK IT IS BECAUSE OF THE SUGAR THAT THE TWIST CAP NO LONGER OPENS DUE TO THE HARDENING OF THE SUGAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918218 ↗
• MalfunctionNov 15, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CONNECTOR CRACKED CAUSING IT TO LEAK. THE DEVICE HAD TO BE CHANGED. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL TIME FOR THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Skin Inflammation/ Irritation

  MAUDE report 12813621 ↗
• MalfunctionNov 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE CONNECTOR CRACKED DURING USE AFTER SEVERAL MONTHS CAUSING THE FEEDING TUBE TO LEAK FORMULA. AS A RESULT, THE FEEDING TUBE WAS REPLACED PREMATURELY. THERE WAS NO PATIENT INJURY AND THERE WAS NO DELAY TO TREATMENT BECAUSE OF THE INTERVENTION. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 31, 2021 STATED THAT ON (B)(6) 2021, A NURSE HAD NOTICED THAT ONE OF THE TWO TIPS OF THE TUBING WAS BROKEN SO IT WAS DECIDED TO PUT THE FEEDING ON THE SECOND TIP. ON (B)(6) 2021, A DRESSING WAS PUT ON THE ENFIT CONNECTOR OF THE TWO ADMINISTRATION SITES. THE ADMINISTRATION SITE HAD REMAINED BROKEN SINCE (B)(6) 2021 AND WAS READY TO BE DETACHED FROM THE TUBING. THE PGE SHOWED FEEDING AND SOME SCABS WITH FEEDING AROUND IT. DRESSINGS WERE DONE AGAIN AND IT WAS NOTED THAT THE TUBING WOULD BE CHANGED. ON (B)(6) 2021, THERE WERE BILIOUS FLOWS AT THE PGE SITE. ON (B)(6) 2021 THERE WAS A LEAK AT THE PGE AFTER ENTERAL HYDRATION VIA PGE. ON (B)(6) 2021, THE TUBING WAS REMOVED AND EXCHANGED BY ANOTHER TUBING FROM ANOTHER MANUFACTURER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12750978 ↗