AVANOS 40976Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00350770409764), received between Jul 23, 2020 and Jul 27, 2023 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED 09-AUG-2023 STATING THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WAS PLACED (B)(6) 2023. THE DEVICE WAS REMOVED (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17407008 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED, "DURING INSERTION THE TIP SEPARATED FROM THE CONNECTOR AND WENT INTO THE [ABDOMINAL] CAVITY." THE PATIENT WENT TO SURGERY TO REMOVE THE FOREIGN BODY AND HAVE ANOTHER PEG TUBE INSERTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11901745 ↗
• MalfunctionMay 6, 2021Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED ON 14-APR-2021, AND THE FOLLOWING INFORMATION WAS PROVIDED: "ACCORDING TO INTERVENTIONALIST COMPLICATION FRACTURE OF THE EXISTING GASTROSTOMY TUBE WITH RETAINED INTERNAL BUMPER." THE ORIGINAL INTENDED PROCEDURE WAS "G [GASTROSTOMY] TUBE WAS BEING CHANGED. INSERTED ON (B)(6) 2020 [(B)(6) 2020]." "THIS WAS A PLANNED PROCEDURE." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11787654 ↗
• MalfunctionJul 23, 2020Break; Break

  IT WAS REPORTED, "DURING ATTEMPTED REPLACEMENT OF BUMPER PEG...WHILE DOING TRACTION REMOVAL OF THE EXISTING TUBE (ORIGINALLY PLACED ON (B)(6) 2019) THE TUBE FRACTURED DURING ATTEMPTED TRACTION REMOVAL AND THE REMAINDER IS STILL INSIDE THE PATIENT." THE PHYSICIAN STATED THE PATIENT WAS AT ANOTHER FACILITY AND WAS BEING MONITORED. THE PHYSICIAN STATED THE PATIENT HAD NOT EXHIBITED ANY SYMPTOMS AND THE FRACTURED PART OF THE TUBE WAS STILL INSIDE THE PATIENT, AS FAR AS HE KNEW. ADDITIONAL INFORMATION RECEIVED 06-JUL-2020 STATED THE MUSHROOM (FLANGE) PART OF THE TUBE REMAINED INSIDE THE GASTROINTESTINAL (GI) TRACT. THE PHYSICIAN TRIED TO REFER THE PATIENT FOR ENDOSCOPIC REMOVAL, BUT THE ACCEPTING FACILITY DECLINED TO PERFORM ENDOSCOPY OPTING INSTEAD FOR SERIAL X-RAY EXAMINATIONS. THE INITIAL POST PROCEDURE X-RAY SHOWED THE REMNANT OF THE TUBE INSIDE THE PATIENT'S STOMACH. THE REMNANT HAD NOT BEEN EXTRACTED. A FOLEY TYPE 20-FRENCH TUBE WAS PLACED IN THE STOMA.

  Patient problems: Foreign Body In Patient

  MAUDE report 10314905 ↗

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-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-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-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-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-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-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-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-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