Skip to content

AVANOS 41072Recalls & reported problems

Avanos Medical, Inc. · MIC* Standard PEG Kit - Pull Method · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770410722), received between May 20, 2026 and May 20, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Difficult to Remove1

Patient problems

  • Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 20, 2026Difficult to Remove

    AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO FOR THE FIRST REPORT. REFER TO FOR THE SECOND REPORT. THE CUSTOMER REPORTED THAT DURING ATTEMPTED REMOVAL OF AVANOS PEG TUBES, THE INTERNAL BUMPER DETACHED FROM THE TUBE AND REMAINED IN THE PATIENT¿S STOMACH RATHER THAN BEING REMOVED THROUGH THE ABDOMEN AS EXPECTED. ENDOSCOPY PHYSICIANS INITIALLY ATTEMPTED BEDSIDE REMOVAL BY TRACTION THROUGH THE ABDOMINAL WALL; HOWEVER, THE BOLSTER REPORTEDLY SEPARATED FROM THE TUBE AND REQUIRED URGENT GASTROSCOPY FOR RETRIEVAL FROM THE STOMACH. THE CUSTOMER REPORTED THAT THIS ISSUE HAD OCCURRED MULTIPLE TIMES. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2026, REPORTING THAT, TO THE BEST OF THE CUSTOMER¿S KNOWLEDGE, TWO INCIDENTS HAD OCCURRED AND THE MOST RECENT EVENT INVOLVED DR. (B)(6). THE CUSTOMER ALSO REPORTED THE PEG TUBES HAD REPORTEDLY BEEN IMPLANTED FOR APPROXIMATELY 6 MONTHS TO 1 YEAR PRIOR TO REMOVAL AND THAT ONLY AVANOS PEG PRODUCTS HAD BEEN USED AT THE FACILITY DURING THAT TIMEFRAME.

    Patient problems: Insufficient Information

    MAUDE report 25233207 ↗

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

Other Tubes, gastrointestinal (and accessories) devices

All Tubes, gastrointestinal (and accessories) devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.