Kangaroo 714200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521010666), received between Feb 3, 2022 and Nov 11, 2024 — classified as 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2024Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED A LEAKY CUFF. 12 DAYS AFTER INSTALLING THE DEVICE, THE BUTTON EXTERNALIZED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20650812 ↗
• MalfunctionJan 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  CUSTOMER REPORTS: THERE IS A HOLE IN THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18469904 ↗
• MalfunctionJan 3, 2024Material Rupture; Material Rupture

  CUSTOMER REPORTS: THE BALLOON ON THE DEVICE BURST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18439857 ↗
• MalfunctionJul 21, 2022Unintended Deflation; Unintended Deflation

  THE CUSTOMER REPORTED THAT THE BUTTON'S BALLOON DEFLATED AND THE BUTTON NEEDED TO BE CHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077455 ↗
• MalfunctionMay 4, 2022Unintended Deflation; Unintended Deflation

  CUSTOMER REPORTS: THE PATIENT UNDERWENT PLACEMENT OF A GASTROSTOMY BUTTON ON (B)(6) 2022, WHILE HOSPITALIZED. SHE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6). ON (B)(6), THE PARENT STATED THAT HE HAD FOUND THE CHILD'S BUTTON EXTERNALIZED AND WAS ABLE TO TELL THAT IT HAD A PUNCTURED BALLOON. HE WAS INSTRUCTED TO REPLACE THE DEVICE BACK INTO THE HOLE RIGHT AWAY SO THAT THE HOLE WOULD NOT CLOSE AND TO KEEP IT FIXED IN PLACE WITH TAPE UNTIL A NEW DEVICE ARRIVED TO MAKE THE CHANGE. ON (B)(6), THE PATIENT EXCHANGED THE DEVICE, SO THAT THE DEFECTIVE DEVICE CAN BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281681 ↗
• MalfunctionFeb 3, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE SHAFT IS BROKEN WHERE IT MEETS THE TOP OF THE TUBE CAUSING PROFUSE LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13445364 ↗