Kangaroo 714170Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521010659), received between Dec 12, 2017 and Nov 13, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE BALLOON BURST ON THE SLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18124266 ↗
• MalfunctionSep 12, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THE SHAFT OF THE PEG IS BROKEN. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE TUBING BELOW THE PIECE THAT SITS ON THE OUTSIDE OF THE SKIN BROKE AT THE TOP, IT SPLIT AND LEAKED. THE DEVICE WAS REPLACED WITHOUT FURTHER MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17732871 ↗
• MalfunctionAug 3, 2023Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE TUBE WAS INSERTED ON (B)(6) 2022 AND A BROKEN SHAFT RESULTED IN LEAKAGE PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2022. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17450489 ↗
• MalfunctionJun 29, 2023Break; Break

  THE CUSTOMER REPORTED THAT THE TUBE WAS INSERTED ON (B)(6) 2023 AND THE RUBBER INSIDE THE TOP OF THE BUTTON (ABOVE VALVE) WHERE THE CONNECTOR PLUGS IN IS BREAKING APART ON (B)(6)2023. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234040 ↗
• MalfunctionJun 23, 2023Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT AFTER THE TEST, THE BUTTON 14FR 1.5CM WAS INSTALLED, BUT AFTER 3 DAYS OF USE, THE BALLOON RUPTURED, MAKING IT IMPOSSIBLE TO USE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17192304 ↗
• MalfunctionJun 22, 2023Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE TUBE WAS INSERTED ON (B)(6) 2023 AND THE BURST BALLOON WAS FOUND ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17187831 ↗
• MalfunctionMar 21, 2023Break; Break

  CUSTOMER REPORTS: THE TUBE WAS INSERTED ON (B)(6) 2022 AND A BROKEN SHAFT WAS DISCOVERED AND TUBE WAS REMOVED ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16585645 ↗
• MalfunctionJan 10, 2023Deflation Problem; Deflation Problem

  THE CUSTOMER REPORTED THAT THE TUBE WAS INSERTED ON (B)(6) 2022 AND THE BALLOON BURST ON (B)(6) 2022. THERE WAS NO HARM REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE HOLE CAUSING BALLOON TO DEFLATE AND SIZE OF HOLE NOT SPECIFIED. IT WAS A CLEAN TEAR. THERE WAS A NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132433 ↗
• MalfunctionSep 7, 2022Material Rupture; Material Rupture

  THE CUSTOMER REPORTED THAT THE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15373986 ↗
• InjuryMar 29, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THE PATIENT EXPERIENCED SEVERE PERIGASTROSTOMAL GRANULOMA, WITH CONTINUOUS BLEEDING AND LOCAL INFECTION. THE CUSTOMER BELIEVES THE TOP OF THE BUTTON IS NOT ERGONOMIC AND STATES IT ENTERS WITH GREAT DIFFICULTY. CONSEQUENCES TO THE PATIENT WERE: CAUTERIZATION OF GRANULOMA, PROLONGED THERAPY, AND NEED OF FREQUENT REPLACEMENT.

  Patient problems: Granuloma

  MAUDE report 11582985 ↗
• MalfunctionDec 12, 2017Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED THAT THE G-TUBE WAS INSERTED ON (B)(6) 2017 AND WHEN FLUSHING THE TUBE AFTER INSERTION, FORMULA WAS LEAKING FROM THE VALVE. THE PATIENT'S MOTHER STATED THAT THE LEAKING CONTINUED AT HOME. ON (B)(6) 2017 THE G-TUBE FELL OUT AND A "PINSIZE" HOLE WAS SEEN ON THE BOTTOM OF THE BALLOON WHERE IT ATTACHES TO THE SHAFT AND THERE WAS A LARGE LEAK OF SALINE FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108591 ↗