AVANOS 42-7366Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770460819), received between May 4, 2020 and Jul 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Material Puncture/Hole; Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50035022 ↗
• MalfunctionDec 30, 2025Material Puncture/Hole; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00338 FOR THE FIRST REPORT PER ADDITIONAL INFORMATION RECEIVED ON 10DEC2025, ¿¿THEY EXPERIENCED THAT THE REMOVAL OF THE GUIDEWIRE, PREVIOUSLY RESULTED IN A SIMILAR PERFORATION IN THE SAME PLACE, AND THAT FLUSHING THE TUBE WITH STERILE WATER PRIOR TO INSERTION HAS HELPED THEM TO AVOID A REPEAT OF THE ISSUE.¿

  Patient problems: Insufficient Information

  MAUDE report 23927497 ↗
• MalfunctionDec 30, 2025Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00339 FOR THE SECOND REPORT IT WAS REPORTED, "ATTEMPTED NASOJEJUNAL TUBE PLACEMENT. DEVICE INSERTED WITH NO CONCERNS - AWAITING CONFIRMATION OF POSITION VIA X-RAY WHEN FOUND TO BE LEAKING GASTRIC CONTENTS, AT THE PORT END OF THE TUBE FROM TWO SMALL, HOLES IN THE TUBE ITSELF. ACTIONS TAKEN: TUBE REMOVED, LABELED AND ISOLATED FOR LOCAL CLINICAL GOVERNANCE FOLLOW UP. PATIENT REQUIRED A REPLACEMENT OF NASOJEJUNAL TUBE."

  Patient problems: Insufficient Information

  MAUDE report 23927492 ↗
• MalfunctionOct 7, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE NG (NASOGASTRIC) TUBE BROKE AND WAS LODGED IN THE PATIENT'S ABDOMEN. IT WAS ALSO REPORTED THAT PATIENT WAS VOMITING WITH FEVER. TUBE WAS REPLACED IN NICU (NEWBORN INTENSIVE CARE UNIT). ON (B)(6) 2021 IT WAS REPORTED THAT THE TUBE WAS REPLACED, AND THE FRAGMENT WILL BE PASSED OUT SPONTANEOUSLY. ON (B)(6) 2021 IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME ON OXYGEN AND JEJUNAL FEEDING, THE BROKEN PIECE IS STILL IN SITU WITH SURGICAL PLAN TO CONTINUE TO MANAGE CONSERVATIVELY.

  Patient problems: Fever; Vomiting

  MAUDE report 12590958 ↗
• MalfunctionMay 4, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "6FR WEIGHTED NJ [NASOJEJUNAL] TUBE IN SITU. PATIENT PULLED OUT TUBE AND NEW TUBE REPLACED. ON COMPLETION OF XRAY IT WAS NOTED THAT THE WEIGHT OF THE TUBE HAD DISCONNECTED FROM THE REST OF THE TUBE AND REMAINED IN THE JEJUNUM. PATIENT PASSED THE TUBE NATURALLY AND NO SURGICAL INTERVENTION WAS REQUIRED." DEVICE WAS IN USE FOR 3 DAYS. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 20-APR-2020 INDICATED THE EXACT LOT NUMBER WAS UNKNOWN. THE PATIENT'S CURRENT CONDITION IS "PATIENT IS CURRENTLY HOME."

  Patient problems: Foreign Body In Patient

  MAUDE report 10022681 ↗