AVANOS 44611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770446110), received between Apr 22, 2021 and Apr 30, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2021Migration; Migration

  ADDITIONAL INFORMATION RECEIVED 02-SEP-2021 STATING FOLLOW-UP WITH THE PHYSICIAN NOTED THE COMMON CAUSE IN THE CASE WAS THAT NO PEXY WAS DONE. THE GASTROENTEROLOGIST WORKS WITH A GENERAL SURGEON ON THE PROCEDURE TO PERFORM THE ENDOSCOPY AND STOMA CREATION/PEG PLACEMENT RESPECTIVELY; AND IMPORTANTLY THAT PEXIES HAVE NEVER BEEN PART OF OUR PROCEDURE. THE PATIENT WAS MEDICALLY COMPLICATED WITH UNDERLYING HEALTH ISSUES, CARDIAC, ETC. THE STOMA CAME APART AROUND 3-DAYS POST-OPERATIVELY. THE EXTERNAL DISC NEVER SLIPPED BUT THE PHYSICIAN FELT THE INTERNAL BUMPER WAS 'TOO FLOPPY.' THE PATIENT HAD 'SIGNIFICANT COLONIC STOOL BURDEN' THE CLINICIANS THOUGHT PERHAPS PERISTALSIS COULD HAVE 'PULLED THE STOMACH SO THAT IT SLIPPED OFF OVER THE BUMPER.'

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

  MAUDE report 11757521 ↗
• InjuryApr 22, 2021Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION WAS RECEIVED ON 27-APR-2021 FROM FDA MEDWATCH REPORT # 5100693 AND THE FOLLOWING WAS NOTED: A FEMALE UNDERWENT UNCOMPLICATED PEG PLACEMENT WITH A 14 FR AVANOS BRAND MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY THE PATIENT HAD MIGRATION OF THE TUBE, ALLOWING FORMULA LEAKAGE, PERITONITIS, SEPSIS AND NOW NECROTIZING FASCIITIS (NOTED VIA (B)(4)) WE HAD A SIMILAR EVENT 1 WEEK LATER WITH THE SAME SIZE AND BRAND TUBE WITHOUT OTHER EXPLANATORY FACTORS ON REVIEW OF DATA, ((B)(4)) THIS IS THE 3RD TUBE MIGRATION WITH THIS SIZE AND BRAND IN A 12 MONTH PERIOD AT OUR INSTITUTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fasciitis; Necrosis; Peritonitis

  MAUDE report 11711212 ↗

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-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-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-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-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-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-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-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-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-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-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-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-0566-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
• Z-0565-2022 · Dec 22, 2021 · Terminated
  MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL