AVANOS 44644Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00350770446448), received between Feb 23, 2023 and Jul 14, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816937 ↗
• MalfunctionJul 14, 2026Unintended Movement

  Patient problems: Wound Dehiscence

  MAUDE report 25816936 ↗
• MalfunctionJul 14, 2026Unintended Movement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25816934 ↗
• InjuryJul 11, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE'S "SILICONE LOCKING RING [WAS] LOOSE, CAUSING PEG TUBE TO SLIP INTO PATIENT'S ABDOMEN. THIS LED TO PERITONITIS AND UNEXPECTED RETURN TO [SURGICAL] THEATRE" FOR MEDICAL INTERVENTION.

  Patient problems: Peritonitis

  MAUDE report 17300326 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY) TUBE WAS PLACED ON (B)(6) 2022 AND THE PULL METHOD WAS USED. THE PATIENT SUSTAINED AN ESOPHAGEAL TEAR AFTER PULLING THE PEG TUBE THROUGH. SURGERY WAS REQUIRED FOR ESOPHAGEAL REPAIR. THE PEG TUBE IN-USE FOR 58 DAYS AND WAS REMOVED ON (B)(6) 2023. THE PATIENT'S STATUS WAS REPORTED TO BE IN HOME CARE WITHOUT VENTILATION OR OXYGEN REQUIREMENTS. PER ADDITIONAL INFORMATION RECEIVED ON 06FEB2023, THE PATIENT WAS TRANSFERRED TO ICU (INTENSIVE CARE UNIT) POST OESOPHAGEAL REPAIR AND WAS ON ANTIBIOTICS AND PAIN RELIEF. THE PATIENT IS HOME AND HEALED WELL.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 16432354 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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