Kangaroo 8884720247 (UDI 10192253011562)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10192253011562), received between Mar 4, 2024 and Mar 2, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Fracture

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE LEAKED OUT AND THEN RUPTURED, REQUIRING A TEMPORARY FEEDING TUBE TO BE INSERTED. ADDITIONAL INFORMATION RECEIVED ON 26FEB2026 STATED THAT NO FURTHER DETAILS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489416 ↗
• MalfunctionJan 28, 2026Break; Unintended Deflation

  THE CUSTOMER REPORTED THEY RECEIVED A CALL FROM THE PERSON IN CHARGE STATING THAT THE PROBE HAD BURST AND WAS LEAKING. IT WAS THEN REPLACED WITH A TEMPORARY PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203389 ↗
• MalfunctionJan 26, 2026Break

  THE CUSTOMER REPORTED THE PROBE HAD BURST AND WAS LEAKING. IT WAS REPLACED WITH A TEMPORARY PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184401 ↗
• MalfunctionAug 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE IT WAS NOTED THAT THE TUBE CUFF WAS PUNCTURED. THIS EVENT WAS REPORTED BY (B)(6). NO CUSTOMER INFORMATION WAS PROVIDED THEREFORE ADDITIONAL INFORMATION CANNOT BE REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22782999 ↗
• MalfunctionJul 29, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE G-TUBE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652221 ↗
• MalfunctionJul 29, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE G-TUBE WAS REPLACED ON (B)(6) 2025 AND ON (B)(6) "2026" THE G-TUBE BALLOON RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22652138 ↗
• MalfunctionJun 5, 2025Material Puncture/Hole; Material Puncture/Hole

  THE CUSTOMER REPORTED THAT AT THE TIME OF THE GASTROSTOMY SURGERY, THE SURGEON IDENTIFIED THAT THE TUBE (CUFF) WAS PUNCTURED AND THE DEVICE HAS BEEN REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22152240 ↗
• MalfunctionJun 5, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT A RUPTURE OF THE GTT BALLOON WAS OBSERVED AT HOME. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151135 ↗
• MalfunctionMay 12, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE IT WAS NOTED THAT THE PROBE CUFF WAS PUNCTURED. THERE WAS NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006725 ↗
• MalfunctionApr 28, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE PATIENT LOST HER KANGAROO 24 FR GTT (GASTROSTOMY FEEDING TUBE), WHICH WAS INFLATED WITH 15 ML OF AD (DISTILLED WATER) ON (B)(6) 2024, DUE TO A RUPTURE OF THE CUFF. SINCE THIS IS A PATIENT DIAGNOSED WITH ALZHEIMER'S, DM, RECURRENT UTIS AND IS BEDRIDDEN, SHE IS UNDER HOME CARE WITH 12 HOURS OF DAYTIME NURSING AND AT NIGHT WITH THE CAREGIVER. SHE HAS LIMITED MOVEMENT, FOR THIS REASON SHE DOES NOT PULL THE GTT. THE TECHNICIANS AND CAREGIVERS ARE COMPLETELY CAUTIOUS, CAPABLE AND EXPERIENCED IN HANDLING, ADMINISTERING MEDICATIONS, DIET AND LIQUIDS THROUGH THIS DEVICE. THE DEVICE HAD TO BE CHANGED BY A PROFESSIONAL DUE TO THE RUPTURED CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919062 ↗
• MalfunctionApr 28, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE PATIENT LOST HER KANGAROO 24 FR GTT (GASTROSTOMY FEEDING TUBE), WHICH WAS INFLATED WITH 8 ML OF AD (DISTILLED WATER) ON (B)(6) 2025, DUE TO A RUPTURE OF THE CUFF. SINCE THIS IS A PATIENT DIAGNOSED WITH ALZHEIMER'S, DM, RECURRENT UTIS AND IS BEDRIDDEN, SHE IS UNDER HOME CARE WITH 12 HOURS OF DAYTIME NURSING AND AT NIGHT WITH THE CAREGIVER. SHE HAS LIMITED MOVEMENT, FOR THIS REASON SHE DOES NOT PULL THE GTT. THE TECHNICIANS AND CAREGIVERS ARE COMPLETELY CAUTIOUS, CAPABLE AND EXPERIENCED IN HANDLING, ADMINISTERING MEDICATIONS, DIET AND LIQUIDS THROUGH THIS DEVICE. THE CUFF RUPTURED ON (B)(6) 2025 AND HAD TO BE CHANGED BY A PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919060 ↗
• MalfunctionApr 28, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THE PATIENT LOST HER KANGAROO 24 FR GTT (GASTROSTOMY FEEDING TUBE), WHICH WAS INFLATED WITH 10 ML OF AD (DISTILLED WATER) ON (B)(6) 2025, DUE TO A RUPTURE OF THE CUFF. SINCE THIS IS A PATIENT DIAGNOSED WITH ALZHEIMER'S, DM, RECURRENT UTIS AND IS BEDRIDDEN, SHE IS UNDER HOME CARE WITH 12 HOURS OF DAYTIME NURSING AND AT NIGHT WITH THE CAREGIVER. SHE HAS LIMITED MOVEMENT, FOR THIS REASON SHE DOES NOT PULL THE GTT. THE TECHNICIANS AND CAREGIVERS ARE COMPLETELY CAUTIOUS, CAPABLE AND EXPERIENCED IN HANDLING, ADMINISTERING MEDICATIONS, DIET AND LIQUIDS THROUGH THIS DEVICE. THE DEVICE HAD TO BE CHANGED BY A PROFESSIONAL DUE TO THE RUPTURED CUFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919058 ↗
• MalfunctionJan 13, 2025Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED AT THE TIME OF THE GASTROSTOMY SURGERY, THE SURGEON IDENTIFIED THAT THE TUBE'S CUFF WAS PUNCTURED, REQUIRING REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137797 ↗
• MalfunctionMar 4, 2024Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE GASTROSTOMY TUBE WAS INSERTED ON (B)(6) 2023 AND EXTERNALIZED DUE TO A BREAKAGE OF THE FIXATION CUFF ON (B)(6) 2024. PER ADDITIONAL INFORMATION RECEIVED ON 3/4/24, THE FIXATION CUFF HAS BEEN IDENTIFIED AS THE INFLATION BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18831802 ↗