Kangaroo 8884720221 (UDI 10884521007321)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10884521007321), received between Jan 4, 2018 and Jul 29, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (10 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT UPON OPENING THE GTT AND PERFORMING THE BALLOON TEST, IT WAS FULL OF PUNCTURES. THE CUSTOMER ALSO STATES THAT THE PRODUCT PACKAGING WAS INTACT, WITH NO SIGNS OF DAMAGE OR POOR STORAGE THAT COULD HAVE CAUSED THE BALLOON TO BECOME PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22653729 ↗
• MalfunctionAug 15, 2023Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT THE DEVICE DID NOT WORK (BALLOON DID NOT INFLATE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552953 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BURST BALLOON (PERFORATED).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451868 ↗
• MalfunctionApr 14, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON BROKE. NO OTHER INFORMATION WAS ABLE TO BE OBTAINED AS THE EVENT WAS REPORTED ANONYMOUSLY TO ANVISA IN BRAZIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746625 ↗
• MalfunctionMar 22, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THE ITEM BURST WITHOUT WARNING. ADDITIONAL INFORMATION RECEIVED ON 16MAR2023 STATED IT FAILED BY THE BALLOON THAT IS DESIGNED TO HOLD THE TUBE AGAINST THE STOMACH WALL TO KEEP IT TIGHT PREVENTING LEAKAGE. ADDITIONAL INFORMATION RECEIVED ON 27MAR2023 STATED THAT IT BURST WITHOUT WARNING WHEN THE DOCTOR TRIED TO INSERT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591776 ↗
• MalfunctionMar 22, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THE ITEM BURST WITHOUT WARNING. ADDITIONAL INFORMATION RECEIVED ON 16MAR2023 STATED IT FAILED BY THE BALLOON THAT IS DESIGNED TO HOLD THE TUBE AGAINST THE STOMACH WALL TO KEEP IT TIGHT PREVENTING LEAKAGE. ADDITIONAL INFORMATION RECEIVED ON 27MAR2023 STATED THAT IT BURST WITHOUT WARNING WHEN THE DOCTOR TRIED TO INSERT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591774 ↗
• MalfunctionMar 22, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THE ITEM BURST WITHOUT WARNING. ADDITIONAL INFORMATION RECEIVED ON 16MAR2023 STATED IT FAILED BY THE BALLOON THAT IS DESIGNED TO HOLD THE TUBE AGAINST THE STOMACH WALL TO KEEP IT TIGHT PREVENTING LEAKAGE. IT BURST WITHOUT WARNING. NECESSITATING A CALL TO 911 TO BE TAKEN TO THE ER. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591772 ↗
• MalfunctionFeb 17, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED A BALLOON RUPTURE AFTER ONLY 12 HOURS OF USE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396538 ↗
• MalfunctionJan 13, 2023Fluid/Blood Leak; Unintended Deflation; Fluid/Blood Leak; Unintended Deflation

  CUSTOMER REPORTS: THE PROBE LEAKED AFTER 24 HOURS OF USE. IT WAS NECESSARY TO EXCHANGE THE PROBE. ADDITIONAL INFORMATION RECEIVED ON 1/11/23 CLARIFIED THAT THE PROBE REFERS TO THE BALLOON IN THIS CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16159665 ↗
• MalfunctionSep 12, 2022Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE BALLOON WAS BROKEN. ON 09/09/22, PER ADDITIONAL INFORMATION, THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15398634 ↗
• MalfunctionJun 29, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BUBBLE/BULB BURST WHEN FILLED WITH STERILE WATER. THE NURSE USED A 10ML SYRINGE TO FILL IT WITH 15ML OF WATER SO IT WASN'T OVERFILLED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854393 ↗
• MalfunctionJun 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE PATIENT INDICATED THAT THE PRODUCT HAS A FAULT, IT HAS A LEAK. NO INJURIES OCCURRED. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6) 2022, THE LEAK WAS COMING FROM THE TUBING. THE ISSUE WAS RESOLVED BY PLACING ADHESIVE TAPE WHERE THE HOLE WAS WHILE THEY GOT ANOTHER CATHETER, THEN IT WAS REMOVED AND REPLACED WITH A DIFFERENT BRAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14778594 ↗
• MalfunctionMay 19, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE PATIENT HAD A GASTROSTOMY TUBE THAT WAS NOT FIXED. WHEN REMOVING IT, IT WAS NOTICED THAT THE BALLOON WAS BROKEN, WHICH CAUSED THE EVENT. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022, THERE WAS NO MEDICAL INTERVENTION GIVEN. THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14434520 ↗
• MalfunctionApr 27, 2022Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THEY WERE TREATING A 16 YEAR OLD FEMALE PATIENT WITH A DIAGNOSIS OF SPASTIC CEREBRAL PALSY. THEY WERE HAVING A PROBLEM WITH THE BALLOON WHICH WAS DAMAGED. THE DEVICE IS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 14218435 ↗
• MalfunctionMar 8, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE PATIENT HAD A GASTROSTOMY TUBE WITH A BURST BALLOON AND IN BAD CONDITION WHICH DISPLACED THE BALLOON WITHOUT PRIOR MANIPULATION. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694078 ↗
• MalfunctionNov 11, 2021Material Perforation

  THE CUSTOMER REPORTED THAT AT THE TIME OF TESTING THE GASTRO TUBE, IT WAS PERFORATED.

  Patient problems: Insufficient Information

  MAUDE report 12800123 ↗
• MalfunctionAug 17, 2021Material Perforation; Material Perforation

  THE CUSTOMER, WHO IS THE HEAD OF SURGERY NURSING, REPORTED THAT AT THE TIME OF TESTING THE GASTRO TUBE IT WAS FOUND TO BE PERFORATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12330945 ↗
• MalfunctionApr 16, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THERE WAS A LEAK WHILE THE PROBE REMAINED IN THE PATIENT. ADHESIVE TAPE WAS USED WHERE THE DIET WAS LEAKING TO FIX THE ISSUE AND AS A RESULT THE PATIENT STARTED TO PRESENT AN INJURY AROUND THE ORIFICE. ADDITIONAL INFORMATION PROVIDED STATED THAT THE LEAK AND THE HUMIDITY CAUSED A WOUND AROUND THE TUBE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INJURY.

  Patient problems: Irritation

  MAUDE report 9969701 ↗
• MalfunctionJan 4, 2018Leak/Splash; Leak/Splash

  THE CUSTOMER STATES THAT THEY INSERTED THE G TUBE ON (B)(6) 2017 AND IT STARTED TO LEAK ON (B)(6) 2017. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7163446 ↗