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
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, ClassifiedProduct 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, ClassifiedProduct 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, ClassifiedProduct 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, ClassifiedProduct 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, ClassifiedProduct 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, ClassifiedProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 24 Fr PULL Model/Catalog Number: 7180-24
- Z-2343-2026 · Apr 30, 2026 · Open, ClassifiedProduct 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, ClassifiedProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 20 Fr PULL Model/Catalog Number: 7180-20
- Z-2347-2026 · Apr 30, 2026 · Open, ClassifiedProduct 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, ClassifiedProduct Name: MIC Safety Percutaneous Endoscopic Gastrostomy PEG Kit 14 Fr PULL Model/Catalog Number: 7180-14
- Z-2350-2026 · Apr 30, 2026 · Open, ClassifiedProduct 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, ClassifiedProduct 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 · TerminatedMIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL
- Z-0566-2022 · Dec 22, 2021 · TerminatedMIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL
Other Tubes, gastrointestinal (and accessories) devices
- Bard® DigniShield® Stool Management System SMS002C. R. Bard, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)2 deaths525 reports
- CORTRAK* 2 ENTERAL ACCESS SYSTEM 20-0950Avanos Medical, Inc. · Tubes, gastrointestinal (and accessories)1 recall22 deaths134 reports
- Bard Tri-Funnel Replacement Gastrostomy Tube 000720Bard Access Systems, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 death170 reports
- EndoVive Safety PEG Kit M00566470Boston Scientific Corporation · TUBES, GASTROINTESTINAL (AND ACCESSORIES)1 recall1 death111 reports
- Kangaroo 8884711253Cardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)152 reports
- Kangaroo 8884711253ECardinal Health, Inc. · TUBES, GASTROINTESTINAL (AND ACCESSORIES)100 reports
- NutraGlide Nasal Feeding Tube ENFT-05055-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.