AVANOS 44603Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770446035), received between Jun 17, 2021 and Feb 24, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

14 other recalls cover devices cleared under the same FDA submission (K924065); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 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 3006646024-2022-00003 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE BUMPER BROKE OFF THE TUBE DURING AN ATTEMPTED TRACTION REMOVAL; THE BUMPER HAD TO BE REMOVED VIA SCOPE IN THE GASTROENTEROLOGY LAB. THERE WAS NO REPORT OF INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13594434 ↗
• MalfunctionFeb 24, 2022Break; Crack; Material Split, Cut or Torn; Break; Crack; Material Split, Cut or Torn

  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 3006646024-2022-00004 FOR THE SECOND REPORT . IT WAS REPORTED THAT THE BUMPER BROKE OFF THE TUBE DURING AN ATTEMPTED TRACTION REMOVAL; THE BUMPER HAD TO BE REMOVED VIA ENDOSCOPY ON (B)(6) 2022 IN THE GASTROENTEROLOGY LAB. THERE WAS NO REPORT OF INJURY. ADDITIONAL INFORMATION RECEIVED 04FEB2022, REPORTED, THAT THE PEG TUBE HAD BEEN IN PLACE FOR 3 MONTHS.

  Patient problems: Foreign Body In Patient

  MAUDE report 13594425 ↗
• InjuryJul 19, 2021Appropriate Device Problem Term/Code Not Available; Migration; Appropriate Device Problem Term/Code Not Available; Migration

  PER ADDITIONAL INFORMATION RECEIVED 03 AUG 2021 FROM THE NUTRITION NURSE, THE ASSUMPTION WAS THAT THE PEG WAS DISLODGED AND MIGRATED, IT DID NOT BREAK, AND IT REMAINS IN THE PATIENT'S ABDOMINAL WALL AT THIS TIME. A CT SCAN WAS PERFORMED AT SOME POINT AFTER THE PROCEDURE AND REVEALED THAT THE PEG WAS NOT CONNECTED WITH THE LUMEN OF GASTROINTESTINAL TRACT IT WAS DISLODGED FROM ITS ORIGINAL SITE. THE NUTRITION NURSE FEELS THAT THE PEG MAY HAVE BEEN PULLED OUT, BY PATIENT OR OTHER. THERE WAS NO CONFIRMATION OF THE INITIAL CORRECT PLACEMENT OF THE PEG VIA X-RAY OR OTHER SCAN, "AS NORMALLY IT IS NOT NECESSARY FROM CLINICAL POINT OF VIEW." HOWEVER, SHE DOES CONFIRM THAT THERE WAS NOTHING INDICATING THAT IT WAS NOT PLACED CORRECTLY. ADDITIONAL INFORMATION INCLUDED THAT NO SUTURES WERE USED, AS THAT IS NOT THEIR NORMAL PROTOCOL FOR PEG PLACEMENT. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021 FROM THE REHABILITATION CENTER AND IS EATING AND DRINKING. THE DECISION WAS MADE TO NOT REMOVE THE PEG OR PLACE A NEW ONE BASED ON THE PATIENT'S COMORBIDITIES AND FRAGILE CONDITION, AND THAT THE PEG TUBE WAS NOT TO BE USED.

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

  MAUDE report 12192747 ↗
• MalfunctionJun 17, 2021Break; Migration; Break; Migration

  IT WAS REPORTED VIA FDA MEDWATCH REPORT 5100693 THE TUBE WAS PLACED ON (B)(6) 2020. THE PATIENT DEVELOPED PAIN WITH FLUSHING AND THE TUBE CRACKED ON (B)(6) 2020. THE PEG BUMPER WAS FOUND TO BE DISPLACED IN THE ANTERIOR ABDOMINAL WALL ON (B)(6) 2020. THE BROKEN DEVICE REQUIRED PEG REMOVAL VIA LAPAROSCOPIC GT ON (B)(6) 2020. THERE WERE NO FURTHER COMPLICATIONS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 12019115 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924065. One submission often covers many models, so check the product and lot details in each record.

• Z-2343-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PUSH OTW Model/Catalog Number: 7170-24 Product Description: Feeding Tube Kit Component: No
• Z-2348-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PUSH OTW Model/Catalog Number: 8170-20
• Z-2352-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PULL Model/Catalog Number: 8180-24
• Z-2346-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
• Z-2349-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 24 Fr PUSH OTW Model/Catalog Number: 8170-24
• Z-2347-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PUSH OTW Model/Catalog Number: 8170-14 Product Description: Feeding Tube Kit Comp
• Z-2350-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 14 Fr PULL Model/Catalog Number: 8180-14
• Z-2345-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
• Z-2342-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PUSH OTW Model/Catalog Number: 7170-20 Product Description: Feeding Tube Kit Component: No
• Z-2341-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PUSH OTW Model/Catalog Number: 7170-14 Product Description: Feeding Tube Kit
• Z-2344-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
• Z-2351-2026 · Apr 30, 2026 · Open, Classified
  Product Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors 20 Fr PULL Model/Catalog Number: 8180-20
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
• Z-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL