Kangaroo 8884715148 (UDI 10884521007222)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521007222), received between Jul 15, 2019 and Nov 20, 2025 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE PROBE HAD A TORN CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23609515 ↗
• MalfunctionAug 15, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THEY PUT A NEW G-TUBE IN THE PATIENT LAST WEDNESDAY AND IT FELL OUT ON THURSDAY. THEY NOTICED THAT THE BALLOON HAD DEFLATED ON ITS OWN AND TESTED TO SEE IF THE BALLOON WAS COMPROMISED. THE BALLOON WON'T INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22814769 ↗
• MalfunctionMar 21, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE CIPE TEAM CHANGED THE PROBE 3 TIMES IN SHORT PERIODS DUE TO CUFF PERFORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662491 ↗
• MalfunctionOct 25, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE PATIENT HAS A KANGAROO GASTROSTOMY TUBE WITH Y PORT. AS PER MANUFACTURER'S INSTRUCTIONS, THE G-TUBE BALLOON IS DEFLATED AND RE-INFLATED. HOWEVER, THE DAILY DEFLATING AND RE-INFLATING, WEAKENED THE RETENTION BALLOON AND THE PATIENT EXPERIENCED A RUPTURING OF THE RETENTION BALLOON WHILE THE TUBE WAS IN USE. STAFF NOTICED THIS AFTER SOME TIME AS THE GASTRIC TUBE WAS SLIDING OUT. ALSO, THERE WAS SOME FRICTION RELATED REDNESS AT THE INSERTION SITE AS THE TUBE WAS ABLE TO SLIDE IN AND OUT DURING USE. IT IS UNCLEAR WHY THE MANUFACTURER'S INSTRUCTION'S REQUIRE DAILY VS WEEKLY DEFLATING AND REFLATING OF THE GASTRIC TUBE BALLOON. UNFORTUNATELY, THE FAULTY G-TUBE WAS THROWN OUT BY STAFF DURING THE EXCHANGE PROCESS, THUS A LOT NUMBER CANNOT BE PROVIDED. THE TUBE WAS ALSO INITIALLY INSERTED IN COMMUNITY (LTC). THIS IS ALSO NOT THE FIRST TIME THAT WE HAVE EXPERIENCED THIS AT THE BEDSIDE. UNFORTUNATELY, WITH PREVIOUS G-TUBE BALLOON RUPTURE, STAFF DID NOT REPORT TO THIS. THERE WAS REDNESS AT THE INSERTION SITE INDICATIVE OF FRICTION IRRITATION DUE TO RETENTION BALLOON FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005801 ↗
• MalfunctionSep 1, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE THE BALLOON WAS RUPTURED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15343408 ↗
• MalfunctionJul 13, 2022Break; Break

  THE CUSTOMER REPORTED WHEN REVIEWING THE GASTROSTOMY TUBE, A SLIGHT RUPTURE IS OBSERVED ALONG THE WHITE LINE (TUNGSTEN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14999396 ↗
• MalfunctionJun 17, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON BURST WHEN BEING INFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14729661 ↗
• MalfunctionDec 23, 2020Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT THE TUBE WAS PUNCTURED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067207 ↗
• InjurySep 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DESCRIPTION AS STATED BY THE HOSPITAL'S MATERIOVIGILANCE OFFICER PROVIDING THE FOLLOWING FACTS: DROPPING ONE OF THE ANCHORAGE DEVICES WITHIN THE SOFT PARTS UNDER THE SKIN INSTEAD OF AN INTRA ABDOMINAL RELEASE. THIS OFF-TARGET DROP CANNOT BE INDIVIDUALIZED IN REAL TIME. CURRENT PATIENT STATUS: THE PATIENT PRESENTED A COLLECTION NEXT TO THE IMPLANTATION SITE. AN CHOGRAPIE MADE AT THE DECODERS MADE IT POSSIBLE TO VISUALIZE THE ANCHOR IN A POSITION UNDER THE SKIN. ACTIONS TAKEN IN THE CARE FACILITY FOR THE CARE OF THE PATIENT: ACTIONS TAKEN IN THE FACILITY WERE TO CHANGE THE GASTROSTOMY DEVICE AT THE PHARMACY. THE FLUID COLLECTION IS A SIGN OF AN ADVERSE EVENT, MOST LIKELY AN INFECTION (SEROMA) CAUSED BY A MISPLACEMENT OF THE DEVICE IN A SUBCUTANEOUS LOCATION RATHER THAN THE INTENDED SITE.

  Patient problems: Seroma

  MAUDE report 10570245 ↗
• MalfunctionJul 15, 2019Obstruction of Flow; Material Split, Cut or Torn; Obstruction of Flow; Material Split, Cut or Torn

  THE CUSTOMER REPORTS CLOGGED FEEDING TUBES AND TUBES SPLITTING.

  Patient problems: No Information

  MAUDE report 8789946 ↗