Covidien 8884715122ERecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521661622), received between Jun 11, 2021 and Oct 15, 2025 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED COMPLETE DISPLACEMENT OF THE GASTROSTOMY TUBE WAS EVIDENT. UPON DISCHARGE, THE INTERNAL RETENTION BALLOON WAS OBSERVED TO BE DEFLATED, WHICH COULD HAVE FACILITATED ITS ACCIDENTAL DISLODGEMENT. THE PATIENT WAS TAKEN TO SURGERY WITH APPROPRIATE MANAGEMENT AND REMAINS IN THE ICU.

  Patient problems: Insufficient Information

  MAUDE report 23294551 ↗
• MalfunctionFeb 14, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED WHEN MANIPULATING THE PATIENT, THE GASTROSTOMY TUBE WAS DISPLACED. THE BALLOON WAS TESTED WITH WATER, AND IT WAS FOUND TO BE DYSFUNCTIONAL. A FOLEY CATHETER WAS PASSED WITHOUT RESISTANCE, AND THE BALLOON WAS INSUFFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18702869 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED EVIDENCE AT THE TIME OF FEEDING THAT ONE PARTITION GASTROTOMY PORT WHERE THE FEEDING EXITS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17347428 ↗
• MalfunctionMar 10, 2023Deflation Problem; Detachment of Device or Device Component; Deflation Problem; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 12 FR KANGAROO G-TUBE HAD A BROKEN MED PORT AND BALLOON. THE TUBE WAS INSERTED ON (B)(6) 2023 AND IT WAS BROKEN ON (B)(6) 2023. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE Y-PORT WAS DETACHED FROM THE TUBE. PER CUSTOMER, THERE WAS NO WATER IN THE BALLOON AT THE TIME OF THE CHANGE AND WHEN THE TUBE WAS REMOVED. THE CUSTOMER IS NOT SURE IF THE BALLOON WAS DEFLATED WITH A PIN HOLE OR LEAK. UNFORTUNATELY, THEY DID NOT LOOK AT IT THAT CLOSELY TO INVESTIGATE IF IT WAS RUPTURED OR LEAKING. THERE WERE NO FRAGMENTED PIECES LEFT INSIDE THE PATIENT INVOLVED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526384 ↗
• MalfunctionMar 6, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CHARGE TECHNOLOGIST FOR INTERVENTIONAL RADIOLOGY REPORTED THAT ONE OF THE TECHNICIANS SAID THE ENFIT END BROKE BELOW THE ACTUAL CONNECTION ON THE KANGAROO FEEDING TUBE FOR ONE OF THE INPATIENTS. ADDITIONAL INFORMATION RECEIVED STATED THE DEVICE HAD A BREAK AT THE FEED AND MEDICATION PORT CAUSING A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485626 ↗
• MalfunctionMar 6, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CHARGE TECHNOLOGIST FOR INTERVENTIONAL RADIOLOGY REPORTED THE ENFIT END IS BREAKING BELOW THE ACTUAL CONNECTION ON THE KANGAROO FEEDING TUBES. ADDITIONAL INFORMATION RECEIVED STATED THE DEVICE HAD A BREAK AT THE FEED AND MEDICATION PORT CAUSING A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485472 ↗
• MalfunctionMar 6, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CHARGE TECHNOLOGIST FOR INTERVENTIONAL RADIOLOGY REPORTED THE ENFIT END IS BREAKING BELOW THE ACTUAL CONNECTION ON THE KANGAROO FEEDING TUBES. ADDITIONAL INFORMATION RECEIVED STATED THE DEVICE HAD A BREAK AT THE FEED AND MEDICATION PORT CAUSING A LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485285 ↗
• MalfunctionJan 31, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED AND FELL OUT.

  Patient problems: Unintended Extubation

  MAUDE report 16271979 ↗
• MalfunctionNov 14, 2022Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THE CUSTOMER REPORTED THAT THE TUBE HAD A LEAK AND THEY VERIFIED IT VIA THE BREAKAGE OF THE UNION OF THE KEY. THE PATIENT WAS A MALE UNDER THE AGE OF ONE. HE WAS IN THE HOSPITAL WITH A MEDICAL DIAGNOSIS OF MIXED CHRONIC MALNUTRITION, NEUROGENIC DYSPHAGIA AND DILATATED HEART DISEASE. PER ADDITIONAL INFORMATION RECEIVED, THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. "BREAKAGE OF THE UNION OF THE KEY" REFERS TO THE TUBE RUPTURING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15792617 ↗
• MalfunctionNov 24, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A CRACK BETWEEN THE Y OF THE CONNECTOR CAUSING FORMULA TO LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869231 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE ENDOSCOPY DEPARTMENT, THE HOSPITAL RECENTLY SWITCHED TO A NEW SYSTEM FOR PEG PROBES. THEY NOW USE THE KANGAROO GASTROSTOMY FEEDING TUBES WITH ENFIT Y-PORTS. THE ENDOSCOPIC DEPARTMENT STATED THAT THE PATIENT RETURNED WITH A DEFECTIVE CONNECTION. THE NURSE HAD TO TAKE A NEW PRODUCT AND TAKE THE CONNECTOR FROM THE NEW PRODUCT TO SWITCH IT WITH THE DAMAGED CONNECTOR. A REPRESENTATIVE PHOTO WAS PROVIDED AND SHOWED THAT THE Y-PORT CRACKED IN THE CENTER. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON JUNE 04, 2021 STATED THAT THE DEVICE DID LEAK BECAUSE OF THE Y-PORT BEING TORN. AFTER ATTACHING THE FEEDING TUBE ON THE ENFIT PORT, THEY WERE NOT ABLE TO UNSCREW THE FEEDING TUBE FROM THE ENFIT PORT, THEREFOR THE Y-PORT TORE AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982247 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE ENDOSCOPY DEPARTMENT, THE HOSPITAL RECENTLY SWITCHED TO A NEW SYSTEM FOR PEG PROBES. THEY NOW USE THE KANGAROO GASTROSTOMY FEEDING TUBES WITH ENFIT Y-PORTS. THE ENDOSCOPIC DEPARTMENT STATED THAT THE PATIENT RETURNED WITH A DEFECTIVE CONNECTION. THE NURSE HAD TO TAKE A NEW PRODUCT AND TAKE THE CONNECTOR FROM THE NEW PRODUCT TO SWITCH IT WITH THE DAMAGED CONNECTOR. A REPRESENTATIVE PHOTO WAS PROVIDED AND SHOWED THAT THE Y-PORT CRACKED IN THE CENTER. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE DEVICE DID LEAK BECAUSE OF THE Y-PORT BEING TORN. AFTER ATTACHING THE FEEDING TUBE ON THE ENFIT PORT, THEY WERE NOT ABLE TO UNSCREW THE FEEDING TUBE FROM THE ENFIT PORT, THEREFOR THE Y-PORT TORE AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982240 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE ENDOSCOPY DEPARTMENT, THE HOSPITAL RECENTLY SWITCHED TO A NEW SYSTEM FOR PEG PROBES. THEY NOW USE THE KANGAROO GASTROSTOMY FEEDING TUBES WITH ENFIT Y-PORTS. THE ENDOSCOPIC DEPARTMENT STATED THAT THE PATIENT RETURNED WITH A DEFECTIVE CONNECTION. THE NURSE HAD TO TAKE A NEW PRODUCT AND TAKE THE CONNECTOR FROM THE NEW PRODUCT TO SWITCH IT WITH THE DAMAGED CONNECTOR. A REPRESENTATIVE PHOTO WAS PROVIDED AND SHOWED THAT THE Y-PORT CRACKED IN THE CENTER. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON JUNE 04, 2021 STATED THAT THE DEVICE DID LEAK BECAUSE OF THE Y-PORT BEING TORN. AFTER ATTACHING THE FEEDING TUBE ON THE ENFIT PORT, THEY WERE NOT ABLE TO UNSCREW THE FEEDING TUBE FROM THE ENFIT PORT, THEREFOR THE Y-PORT TORE AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982230 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE ENDOSCOPY DEPARTMENT, THE HOSPITAL RECENTLY SWITCHED TO A NEW SYSTEM FOR PEG PROBES. THEY NOW USE THE KANGAROO GASTROSTOMY FEEDING TUBES WITH ENFIT Y-PORTS. THE ENDOSCOPIC DEPARTMENT STATED THAT THE PATIENT RETURNED WITH A DEFECTIVE CONNECTION. THE NURSE HAD TO TAKE A NEW PRODUCT AND TAKE THE CONNECTOR FROM THE NEW PRODUCT TO SWITCH IT WITH THE DAMAGED CONNECTOR. A REPRESENTATIVE PHOTO WAS PROVIDED AND SHOWED THAT THE Y-PORT CRACKED IN THE CENTER. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON JUNE 04, 2021 STATED THAT THE DEVICE DID LEAK BECAUSE OF THE Y-PORT BEING TORN. AFTER ATTACHING THE FEEDING TUBE ON THE ENFIT PORT, THEY WERE NOT ABLE TO UNSCREW THE FEEDING TUBE FROM THE ENFIT PORT, THEREFOR THE Y-PORT TORE AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982228 ↗
• MalfunctionJun 11, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT IN THE ENDOSCOPY DEPARTMENT, THE HOSPITAL RECENTLY SWITCHED TO A NEW SYSTEM FOR PEG PROBES. THEY NOW USE THE KANGAROO GASTROSTOMY FEEDING TUBES WITH ENFIT Y-PORTS. THE ENDOSCOPIC DEPARTMENT STATED THAT THE PATIENT RETURNED WITH A DEFECTIVE CONNECTION. THE NURSE HAD TO TAKE A NEW PRODUCT AND TAKE THE CONNECTOR FROM THE NEW PRODUCT TO SWITCH IT WITH THE DAMAGED CONNECTOR. A REPRESENTATIVE PHOTO WAS PROVIDED AND SHOWED THAT THE Y-PORT CRACKED IN THE CENTER. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2021 STATED THAT THE DEVICE DID LEAK BECAUSE OF THE Y-PORT BEING TORN. AFTER ATTACHING THE FEEDING TUBE ON THE ENFIT PORT, THEY WERE NOT ABLE TO UNSCREW THE FEEDING TUBE FROM THE ENFIT PORT, THEREFOR THE Y-PORT TORE AND LEAKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11982216 ↗