AVANOS 45837Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770458373), received between Mar 6, 2023 and Oct 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEVELOPED A WOUND ON THE NOSE THAT "APPEARED TO BE RELATED TO THE STRING PULLING MORE TO THE SIDE WITH THE WEIGHT OF THE TUBE." ADDITIONAL INFORMATION RECEIVED 03-OCT-2023 STATING "THE CORGRIP WAS PLACED ON (B)(6) 2023. THE WOUND WAS ON THE BRIDGE OF THE NOSE. IT APPEARED THE STRING ITSELF WAS RUBBING ON THIS AREA, NOT THE CLIP ITSELF. PER THE NURSE, THERE WAS SPACE BETWEEN THE CLIP AND THE STRING, BUT THE ACTUAL TUBE WAS PULLING THE BRIDLE TO THE SIDE AND RUBBING ONTO THE NOSE. NONE OF THE DIETITIANS ACTUALLY VISUALIZED THIS FOR CONFIRMATION HOWEVER BECAUSE THE BRIDLE WAS ALREADY REMOVED ONCE THE WOUND WAS IDENTIFIED, SO IT IS BASED ON REPORT ONLY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18007447 ↗
• MalfunctionSep 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY A NURSE, ¿DURING THE INSERTION OF A FIXATION SYSTEM FOR A NASOGASTRIC FEEDING TUBE (CORGRIP), ONE OF THE RODS WAS ¿INHALED¿ BY THE PATIENT TO THE BACK OF HIS THROAT, WHILE THE END IS PROVIDED WITH A THICKER TIP. A NECK X-RAY SHOWING THIS ROD IS AVAILABLE IN THE FILE PATIENT'S MEDICAL.¿ NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17777356 ↗
• MalfunctionMar 6, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED, THAT UPON REMOVAL OF THE WHITE CATHETER THE UMBILICAL TAPE WAS NOTED TO NO LONGER HAVE THE MAGNET AND THEY BELIEVED THE MAGNET WAS STILL INDWELLING IN THE PATIENT; THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 13FEB2023 REPORTED, THE NASOGASTRIC (NG) TUBE WAS LEFT IN THE PATIENT AND SECURED WITH TAPE. ON (B)(6) 2023 THE EAR, NOSE AND THROAT (ENT) DOCTOR PERFORMED A NASAL ENDOSCOPE WHICH REVEALED THE PATIENT HAD A DEVIATED NASAL SEPTUM AND NASAL POLYPS; HOWEVER, THEY WERE UNABLE TO LOCATE THE CORGRIP MAGNET. IT WAS ADDITIONALLY REPORTED, THE FAMILY MADE THE DECISION TO NOT PERFORM ANY FURTHER TESTING TO LOCATE THE MAGNET AS THE PATIENT WAS ON END-OF-LIFE CARE FOR A DIAGNOSIS OF METASTATIC BONE CANCER. THE PATIENT EXPIRED, ON (B)(6) 2023, ¿DUE TO [THE] DIAGNOSIS OF METASTATIC BONE CANCER¿.

  Patient problems: Foreign Body In Patient

  MAUDE report 16492377 ↗