AVANOS 44600Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770446004), received between Aug 14, 2020 and Jan 6, 2024 — classified as 1 injury, 7 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2024Material Separation; Material Separation

  IT WAS REPORTED THERE WAS AN EVENT WHERE THE WHITE CATHETER SLIPPED THROUGH THE INCISION AND HAD TO BE RETRIEVED WITH A GRASPER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18461122 ↗
• MalfunctionNov 22, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00035 FOR THE SECOND EVENT. IT WAS REPORTED THE DEVICE BROKE AT THE CONNECTION POINT BETWEEN THE GASTROSTOMY TUBE AND TUNNELER/DILATOR. "IN THIS CASE THE WIRE WAS PULLED THROUGH LOSING ACCESS AND BECAUSE THE TUBE FRACTURED THE GASTROSTOMY TUBE REMAINED IN THE STOMACH/ESOPHAGUS WITHOUT BEING EXTERNALIZED FROM THE PATIENT. THIS REQUIRED GASTROINTESTINAL (GI) AND SURGERY INVOLVEMENT FOR MANAGEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 18194133 ↗
• MalfunctionNov 22, 2023Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2023-00034 FOR THE FIRST EVENT. IT WAS REPORTED THE DEVICE BROKE AT CATHETER BROKE AT THE TUNNELING/EARLY DILATOR PORTION OF THE GASTROSTOMY TUBE." THERE WAS NO PATIENT HARM OCCURRED DUE TO THE HEALTHCARE PROVIDER'S "TIGHT GRASP ON THE WIRE AND THE FACT THAT A SMALL AMOUNT OF TUBE WAS PROTRUDING FROM THE GASTROSTOMY ACCESS SITE." THE HEALTHCARE PROVIDER COMPLETED THE PROCEDURE WITHOUT HARM OR FURTHER COMPLICATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18194130 ↗
• MalfunctionFeb 7, 2023Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2023-00002 FOR THE SECOND REPORT. IT WAS REPORTED, WHEN THE DOCTOR INSERTED THE NEEDLE THE PLASTIC INTRODUCER BENT, WHICH CAUSED THE NEEDLE TO BEND AND BREAK OFF INSIDE OF THE PATIENT. THERE WAS NO REPORTED MEDICAL INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16311379 ↗
• MalfunctionFeb 7, 2023Material Integrity Problem; Material Integrity Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2023-00001 FOR THE FIRST REPORT. IT WAS REPORTED, WHEN THE DOCTOR INSERTED THE NEEDLE THE PLASTIC INTRODUCER BENT, WHICH CAUSED THE NEEDLE TO BEND AND BREAK OFF INSIDE OF THE PATIENT. THERE WAS NO REPORTED MEDICAL INTERVENTION OR INJURY TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16311147 ↗
• MalfunctionJan 17, 2023Material Deformation

  PEG KIT WIRE HAD A KNOT AS IT WAS BEING PULLED FROM THE STOMACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16183373 ↗
• MalfunctionMay 27, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING INSERTION THE CANNULA NEEDLE, WHICH THE GUIDEWIRE GOES THROUGH, CRACKED (OFF) AND SLID INTO THE PATIENT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 REPORTED, THE HUB BROKE OFF THE CANNULA AND SLIPPED INTO THE PATIENT¿S ADIPOSE TISSUE; IT (THE HUB) WAS DUG OUT. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2022 REPORTED, THE PHYSICIAN RETRIEVED THE BROKEN PIECES FROM THE PATIENT WITH HEMOSTATS. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14529555 ↗
• InjuryAug 14, 2020Break; Break

  IT WAS REPORTED A PATIENT CAME IN FOR A PEG TUBE REPLACEMENT. THE OLD PEG TUBE WAS NOT ABLE TO BE REMOVED VIA THE INSERTION SITE, DUE TO RIGIDITY OF THE DISK. IT HAD TO BE REMOVED VIA SCOPE, UP AND THROUGH THE ESOPHAGUS, CAUSING AN ESOPHAGEAL INJURY SEEN VIA COMPUTED TOMOGRAPHY (CT) OF THE HEAD/NECK. THE PATIENT DID NOT REQUIRE INTERVENTION IN THE RECOVERY AREA. ADDITIONAL INFORMATION RECEIVED 29-JUL-2020 STATED THE PATIENT DID NOT REQUIRE ANY SURGICAL INTERVENTION, ONLY ANTIBIOTICS, AND HAS SINCE BEEN DISCHARGED.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 10410662 ↗

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-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-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-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-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-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-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-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