AVANOS 46207Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00350770462073), received between Jul 14, 2020 and Mar 24, 2026 — classified as 1 death, 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2026-00015 FOR THE SECOND REPORT, REFER TO 2026095-2026-00016 FOR THE THIRD REPORT. THE CUSTOMER REPORTED A NUMBER OF INFECTIONS FOLLOWING THE INSERTION OF CORFLO PEG DEVICES BETWEEN DECEMBER AND JANUARY. THE DEVICES HAD BEEN USED FOR AT LEAST ONE YEAR PRIOR WITH NO REPORTED INFECTIONS, AND NO COMMON FACTOR WITHIN THE FACILITY COULD BE IDENTIFIED TO EXPLAIN THE INCREASE.

  Patient problems: Unspecified Infection

  MAUDE report 24681953 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2026-00014 FOR THE FIRST REPORT. REFER TO 2026095-2026-00015 FOR THE SECOND REPORT. THE CUSTOMER REPORTED A NUMBER OF INFECTIONS FOLLOWING THE INSERTION OF CORFLO PEG DEVICES BETWEEN DECEMBER AND JANUARY. THE DEVICES HAD BEEN USED FOR AT LEAST ONE YEAR PRIOR WITH NO REPORTED INFECTIONS, AND NO COMMON FACTOR WITHIN THE FACILITY COULD BE IDENTIFIED TO EXPLAIN THE INCREASE.

  Patient problems: Unspecified Infection

  MAUDE report 24681729 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED MULTIPLE INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2026-00014 FOR THE FIRST REPORT. REFER TO 2026095-2026-00016 FOR THE THIRD REPORT. THE CUSTOMER REPORTED A NUMBER OF INFECTIONS FOLLOWING THE INSERTION OF CORFLO PEG DEVICES BETWEEN DECEMBER AND JANUARY. THE DEVICES HAD BEEN USED FOR AT LEAST ONE YEAR PRIOR WITH NO REPORTED INFECTIONS, AND NO COMMON FACTOR WITHIN THE FACILITY COULD BE IDENTIFIED TO EXPLAIN THE INCREASE.

  Patient problems: Unspecified Infection

  MAUDE report 24675787 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED, "THE WIRE ATTACHED TO THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] SNAPPED WHILST BEING PULLED THROUGH. THE WIRE LOOKS TO HAVE FRAYED ON THE END." ADDITIONAL INFORMATION RECEIVED 01-NOV-2024, STATED "TO RETRIEVE THE PIECE A LARYNGOSCOPE WAS USED ALONG WITH FORCEPS TO REMOVE."

  Patient problems: Foreign Body In Patient

  MAUDE report 20801255 ↗
• MalfunctionNov 7, 2024Difficult to Remove; Material Perforation; Difficult to Remove; Material Perforation

  IT WAS REPORTED VIA MHRA: (B)(4) THE FOLLOWING INFORMATION: "THERE WAS AN INCIDENT WHERE THE WIRE SPLIT THROUGH THE TUBE AT THE END OF THE [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] PEG...CORFLO PEG INSERTED ON (B)(6) 2024. INITIALLY A STRAIGHTFORWARD INSERTION, HOWEVER WIRE SPLIT THROUGH THE TUBE AT THE END OF THE PEG, MAKING IT DIFFICULT TO PULL THROUGH THE STOMACH. THIS CAUSED TRAUMA FOR THE PATIENT AS THE WIRE IS NOT MEANT TO SPLIT THROUGH THE PLASTIC. [OFFICE OF GENERIC DRUGS] OGD SHOWED PEG BUMPER APPROPRIATELY POSITIONED. USE OF PEG WAS HELD FOR 24 HOURS TO ALLOW ABDOMEN TO SETTLE. PEG TIP WAS CUT AND SENT TO MEDICAL PHYSICS WITH ANALYSIS. PATIENT MONITORED CLOSELY POST PEG AND HAS REMAINED STABLE." ADDITIONAL INFORMATION RECEIVED STATED, "PATIENT WAS NOT INJURED HOWEVER THERE WAS A NUMBER OF PROBLEMS POST INSERTION, SUCH AS THE PEG WAS NOT FUNCTIONING AND IT WAS IMPOSSIBLE TO FLUSH THE TUBE. HE NEEDED A [COMPUTED TOMOGRAPHY] CT SCAN AND A TUBOGRAM. THERE WAS SOMETHING WITHIN THE TUBE STOPPING IT FROM BEING FLUSHED AND THIS WAS PUSHED THROUGH WITH A SOFT WIRE 4-DAYS AFTER INSERTION. IT WAS NOT POSSIBLE TO RETRIEVE THIS AS IT WAS DONE IN INTERVENTIONAL RADIOLOGY. THE PATIENT WAS U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20634398 ↗
• MalfunctionApr 2, 2024Break; Break

  IT WAS REPORTED, ¿LAST WEEK WHEN I WAS INSERTING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) ONCE THE GUIDEWIRE HAD BEEN BROUGHT BACK OUT OF THE PATIENT¿S MOUTH IT SNAPPED IN HALF. WE HAD TO TAKE THE WIRE OUT, OPEN A NEW PEG PACK AND RESCOPED THE PATIENT TO PASS ANOTHER WIRE THROUGH THE TROCAR AND BRING IT BACK UP THROUGH THE PATIENT¿S MOUTH.¿ NO INJURY OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020810 ↗
• MalfunctionFeb 16, 2024Degraded; Material Separation; Degraded; Material Separation

  IT WAS REPORTED, ¿CONTACTED BY CONSULTANT IN A&E (ACCIDENT AND EMERGENCY) DEPARTMENT EXPLAINED THAT DISK WAS OUT OF PATIENT FROM HIS GASTROSTOMY TUBE. CARE HOME STAFF REPORTED THAT PATIENT HAD VOMITED BUMPER FROM PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. ON EXAMINATION, PATIENT STILL HAD PEG TUBE IN BUT INTERNAL SPONGE FROM BUMPER HAD BEEN VOMITED UP. THERE WERE CONCERNS THAT THE ACTUAL BUMPER OR PART OF IT HAD COME AWAY FROM THE TUBE, SO PLAN WAS MADE FOR ENDOSCOPY. PATIENT SENT TO ENDOSCOPY FOR TUBE REMOVAL AND RE-INSERTION OF NEW 16 FR CORFLO PEG TUBE. TUBE EXAMINED AND IT LOOKS LIKE THE BOTTOM HALF OF THE BUMPER HAS PARTIALLY DISINTEGRATED AND SPONGE HAD FALLEN OUT. SURPRISING, AS WE KNOW THESE TUBES ARE USUALLY VERY ROBUST, CAN LAST FOR YEARS.¿ THE TUBE WAS PLACED ON (B)(6) 2023 AND WAS IN USE FOR APPROXIMATELY 3.5 MONTHS. NO INJURY REPORTED. THE PATIENT IS BACK HOME AND IS WELL.

  Patient problems: Foreign Body In Patient; Vomiting

  MAUDE report 18724638 ↗
• MalfunctionFeb 5, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED 31-JAN-2024 STATING, "FACILITY STATES THEY FLUSHED TUBE REGULARLY."

  Patient problems: Foreign Body In Patient

  MAUDE report 18647313 ↗
• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED, THAT DURING PULL THROUGH OF THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE, THE LOOP WIRE ON THE PEG SNAPPED, CAUSING THE BUMPER TO BECOME STUCK IN THE BACK OF THE THROAT. THE TUBE HAD TO BE RETRIEVED USING A GASTROSCOPE AND SNARE. THE PROCEDURE WAS RESTARTED FROM THE BEGINNING. MEDICAL TREATMENT INCLUDED ADDITIONAL SEDATION AND INCREASED SUCTIONING AS THE PATIENT BECAME DISTRESSED. THE NEXT DAY, THE PATIENT VOMITED COFFEE GROUND EMESIS. THE PATIENT WAS REPORTED TO BE STABLE BUT FEEDING STOPPED. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE PATIENT IS CLINICALLY STABLE, AND THERE IS NO FURTHER BLEEDING.

  Patient problems: Distress; Hematemesis

  MAUDE report 16906338 ↗
• MalfunctionOct 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA A REPORT RECEIVED FROM THE MHRA ON (B)(6) 2021 THAT THE REPORTER "VISITED THIS GENTLEMAN AS ARRANGED TO TRACTION REMOVE HIS 16FR CORFLO PERCUTANEOUS ENDOSCOPIC GASTROSTOMY ( PEG). THE PEG EXTERNAL LENGTH WAS VERY SHORT APPROXIMATELY 5 INCHES. WHEN TRACTION REMOVING THE PEG HE WAS VERY TENSE AND WAS UNABLE TO RELAX HIS STOMACH MUSCLES, THE EXTERNAL TUBE DETACHED FROM THE INTERNAL BUMPER AND I WAS UNABLE TO VISUALIZE THE BUMPER IN THE STOMA TRACT. I INSERTED A MEASURING DEVICE INTO THE STOMA TRACT AND COULD NOT FEEL THE BUMPER INTERNALLY. STOMA TRACT MEASURED FOR BUTTON BALLOON GASTROSTOMY AND BALLOON GASTROSTOMY PLACED AS PER POLICY. ADVICE GIVEN TO CARE HOME STAFF RE THE BUMPER PASSING THROUGH DIGESTIVE TRACT AND SIGNS AND SYMPTOMS TO LOOK OUT FOR THAT MAY SUGGEST AN OBSTRUCTION. ADVISED TO MONITOR BOWEL MOTIONS AND CONTACT GP IF ANY MEDICAL CONCERNS. REASSURANCE GIVEN THAT THE BUMPER IS VERY SMALL AND SOFT AND SHOULD PASS THROUGH SYSTEM. SPOKE WITH GASTROENTEROLOGIST AND DISCUSSED INCIDENT AND CONSULTANT AGREED WITH CARE PLAN."

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682370 ↗
• MalfunctionOct 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  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 3006646024-2021-00019 FOR THE FIRST REPORT . IT WAS REPORTED THAT "THE INTERNAL BUMPER SEPARATED FROM THE TUBE WHILST TRACTION REMOVING THE PEG TUBE. THIS LEFT THE INTERNAL BUMPER INSIDE THE PATIENT." THE PEG TUBE HAD BEEN PLACED ON (B)(6) 2018.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12682346 ↗
• DeathJun 8, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED 10-JUN-2021 INDICATED THE PATIENT DEVELOPED PERITONITIS WITHIN ONE WEEK OF THE PEG PLACEMENT. THE PATIENT DIED AS A RESULT OF THE PERITONITIS AND FOUR LITERS OF FEED IN THE PERITONEUM. THE DEVICE WAS PLACED BY AN EXPERIENCED USER. ADDITIONAL INFORMATION RECEIVED 18-JUN-2021 INDICATED THE DEVICE WAS PLACED ON (B)(6) 2021. THE EXACT DATE OF DEATH IS UNKNOWN, BUT IT WAS WITHIN 10 DAYS OF PLACEMENT.

  Patient problems: Peritonitis

  MAUDE report 11961650 ↗
• InjuryJun 8, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED 10-JUN-2021 INDICATED THE PATIENT DEVELOPED PERITONITIS WITHIN ONE WEEK OF THE PEG PLACEMENT. THE DEVICE WAS PLACED BY AN EXPERIENCED USER. ADDITIONAL INFORMATION RECEIVED 18-JUN-2021 INDICATED THE DEVICE WAS PLACED ON (B)(6) 2021. AN OESOPHAGOGASTRODUODENOSCOPY (OGD) REVEALED AN OESOPHAGEAL TUMOR AT 30CM. THE PATIENT'S CURRENT CONDITION WAS "OK, EATING AND DRINKING NOW. PEG REMAINS INSITU (NOT USED) AS HIGH RISK TO REMOVE DUE TO PATIENT CO MORBIDITIES AND GA RISK)."

  Patient problems: Peritonitis

  MAUDE report 11961623 ↗
• MalfunctionJul 14, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT "PATIENT HAD PEG INSERTION DONE BY THE ENDOSCOPIST. FAILED ON THE ORIGINAL SITE, SO LEFT THE INTRODUCER NEEDLE CATHETER. THEN LATER WENT AND TRIED ON THE OTHER SIDE. AFTER THE PEG INSERTION, FAILED TO RETRIEVE THE CATHETER FROM THE INITIAL ORIGINAL SITE. NO HARM TO THE PATIENT." CLINICIAN LATER REMOVED THE SHEATH ON POST-OPERATIVE DAY TWO. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10273099 ↗