AVANOS 45885Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770458854), received between Feb 4, 2020 and Apr 26, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2022Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO (B)(4) FOR THE FIRST REPORT. THE NURSE REPORTED THAT DURING THE REMOVAL OF THE 12FR CORFLO PEG TUBE, WHILE THE PATIENT WAS UNDER ANESTHESIA, THE HEALTHCARE PROFESSION PULLED THE PEG TUBE OUT AND THE RING BUMPER WAS RETAINED INSIDE THE PATIENT¿S STOMACH; FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THAT TIME CONCERNING THE INTERVENTION; NO INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 06-APR-2022 REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL 1HOUR AND 15 MINUTES. DUE TO THE PATIENT BEING SO SMALL THEY HAD A DIFFICULT TIME REMOVING THE BUMPER FROM THE STOMACH; MULTIPLE GRASPING DEVICES WERE USED INCLUDING: (WV'S, SNARE, AND ROTH NET). THEY WERE ABLE TO SUCCESSFULLY RETRIEVE THE BUMPER USING A 2ND ROTH NET. THE PATIENT WAS REPORTEDLY DOING WELL WITH NO COMPLICATIONS NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14207665 ↗
• MalfunctionApr 26, 2022Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2022-00042 FOR THE SECOND REPORT. THE NURSE REPORTED THAT DURING THE REMOVAL OF THE 12FR CORFLO PEG TUBE, WHILE THE PATIENT WAS UNDER ANESTHESIA, THE HEALTHCARE PROFESSION PULLED THE PEG TUBE OUT AND THE RING BUMPER WAS RETAINED INSIDE THE PATIENT¿S STOMACH; FURTHER INTERVENTION WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED AT THAT TIME CONCERNING THE INTERVENTION; NO INJURY WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON 06APR2022 REPORTED THAT THE PATIENT WAS UNDER ANESTHESIA FOR AN ADDITIONAL 40 MINUTES; THE ROTH NET BASKET WAS USED TO RETRIEVE THE BUMPER. THE PATIENT WAS REPORTEDLY DOING WELL WITH NO COMPLICATIONS NOTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14207652 ↗
• MalfunctionFeb 4, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT "THERE WAS GAS (FROM THE STOMACH) COMING OUT RIGHT AFTER WE PLACED IT [CORFLO MAX PEG (12 FR)] AND OPENED IT BUT WHEN THEY WERE READY TO INFUSE FLUID, THEY WERE UNABLE TO DO SO. IT SO HAPPENS, WE HAD TO CHANGE THAT TUBE ON POD [POST-OPERATIVE DAY] # 2, WHEN IT WAS NOT VERY SAFE TO DO, BUT WE VERY CAREFULLY DID. THE TUBE HAD A 'DIAPHRAGM' CAUSING AN OBSTRUCTION AT THE TIP BEFORE THE DISC WITH THE SPONGE. ADDITIONAL INFORMATION RECEIVED 16-JAN-2020 INDICATED THAT THERE WERE NO ADVERSE EFFECTS FOLLOWING THE REDO PROCEDURE. PRODUCT LOT CODE WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED 17-JAN-2020 INCLUDED LIMITED PATIENT INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9663271 ↗