AVANOS 40978Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770409788), received between Jun 30, 2021 and Sep 7, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 7, 2021Break; Break

  IT WAS REPORTED THERE WAS "A PEG TUBE BREAK UPON REMOVAL WITH TRACTION FROM PATIENT." THE PEG BROKE BELOW THE SKIN LEVEL WHEN ATTEMPTING TO REMOVE. THE CLINICIANS BROUGHT THE PATIENT OVER TO SEDATE AND PERFORM AN EGD, HOWEVER, THE CLINICIANS WERE UNABLE TO PASS THE SCOPE DUE TO ADVANCED CANCER. THE PATENT WAS HAVING A SURGERY CONSULTATION IN ORDER TO REMOVE THE REMNANT AND PLACE A REPLACEMENT TUBE FOR FUTURE USE. ADDITIONAL INFORMATION RECEIVED 19-AUG-2021 STATED THE PEG WAS PLACED ON (B)(6) 2020. THE DEVICE BROKE DURING TRACTION REMOVAL ON (B)(6) 2021 AND WENT TO THE OPERATING ROOM (OR) AFTERWARD (B)(6) 2021. THE UNDERWENT AN EXPLORATORY LAPAROTOMY, GASTROSTOMY, REMOVAL OF FOREIGN BODY, GASTROSTOMY CLOSURE, AND G-TUBE REPLACEMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2021.

  Patient problems: Foreign Body In Patient

  MAUDE report 12436631 ↗
• MalfunctionJun 30, 2021Break; Break

  IT WAS REPORTED THE PHYSICIAN WAS REMOVING A PEG FROM A PATIENT AND THE PEG BROKE OFF, LEAVING THE BUMPER INSIDE OF THE PATIENT. THERE WAS CONCERN THAT THE BUMPER WAS LODGED IN OR AROUND THE PERITONEUM (FROM WHAT WAS EXPLAINED). THE CLINICIANS TRIED TO REMOVE THE REST OF THE PEG AND IT APPEARED THE DEVICE HAD PASSED THROUGH THE PATIENTS BOWEL. ADDITIONAL INFORMATION RECEIVED 06-JUN-2021 STATED THE DEVICE WAS PLACED ON (B)(6) 2021. THE PATIENT REQUIRED AN EGD ON (B)(6) 2021 TO SEE IF THE BUMPER WAS STUCK, FREE FLOATING, OR PASSED THROUGH THE PATIENT'S STOMACH. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12095858 ↗

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-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-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-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-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-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-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-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-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-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-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