AVANOS 42700Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770427003), received between Jul 22, 2020 and Oct 17, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2025Material Rupture; Material Rupture

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00256 FOR THE SECOND EVENT. IT WAS REPORTED THE MICKEY BUTTON FAILED ON (B)(6) 2025 IN LESS THAN 1-MONTH OF USE. "TUBE CAME OUT OF STOMA AGAIN AND BALLOON WAS NOTED TO BE RUPTURED ON SIDE, 'TATTERED' APPEARANCE.' BACKUP WAS PLACED SO NO ED [EMERGENCY DEPARTMENT] VISIT." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330542 ↗
• MalfunctionOct 17, 2025Malposition of Device; Malposition of Device

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00246 FOR THE SECOND EVENT. IT WAS REPORTED THE MICKEY BUTTON FAILED ON (B)(6) 2025 IN LESS THAN 1-MONTH OF USE. "TUBE DISLODGED FROM STOMA WHILE CHILD WAS AT SUMMER SCHOOL; TUBE WAS LOST. BACKUP UNABLE TO PLACED DUE TO LENGTH OF TIME THAT HAD PASSED; HAD TO TAKE CHILD" TO EMERGENCY DEPARTMENT (ED) AND TUBE WAS REPLACED VIA INTERVENTIONAL RADIOLOGY (IR). THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23330495 ↗
• MalfunctionJul 22, 2020Break; Break

  IT WAS REPORTED, "THE G-TUBE BROKE APART AT THE LEVEL OF THE BOOSTER & STEM-THE BALLOON DEFLATED AND THE DISTAL PORTION MIGRATED INTO THE STOMACH, A TRIP TO THE ED [EMERGENCY DEPARTMENT], DETERMINED THE TUBE WOULD BE ALLOWED TO PASS NATURALLY [THROUGH] THE GI TRACT. A NEW TUBE WAS REPLACED IN THE ED." SINCE THAT TIME, THE PATIENT HAD MULTIPLE "POOPS" AND IT IS BELIEVED THE BROKEN END PIECE WAS PASSED IN THE PATIENT'S FECES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10307557 ↗