AVANOS 44610Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770446103), received between Apr 9, 2020 and Apr 10, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

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.

• MalfunctionApr 10, 2020Break; Break

  AN REPORT WAS RECEIVED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) AND THE FOLLOWING INFORMATION WAS PROVIDED: FROM STAFF- PATIENT PRESENTED TO OUTPATIENT GASTROENTEROLOGY OFFICE FOR A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE REMOVAL. UPON ATTEMPT OF REMOVAL, THE INTERNAL BUMPER FAILED TO COME OUT OF THE PEG. PROVIDER ORDERED A STAT X-RAY OF THE ABDOMEN. PROVIDER DISCUSSED WITH THE RADIOLOGIST AND CONFIRMED THE PEG TUBE BUMPER IS IN THE STOMACH, 2.9 CM FOREIGN BODY IN THE STOMACH LUMEN. FROM GASTROENTEROLOGIST'S OFFICE NOTE REMOVAL OF THE PEG TUBE WAS ATTEMPTED IN THE OFFICE TRACTION TECHNIQUE WAS USED THE INTERNAL BUMPER FAILED TO COME OUT WITH THE FEEDING TUBE STAT X-RAY OF THE ABDOMEN, LATERAL AND AP WAS ORDERED DISCUSSION WITH RADIOLOGIST REVEALED THE PEG TUBE BUMPER IS IN THE STOMACH, 2.9 CM FOREIGN BODY IN THE STOMACH LUMEN PATIENT HAS BEEN TRANSPORTED TO ENDOSCOPY DEPARTMENT FOR FOREIGN BODY REMOVAL WITH ESOPHAGOGASTRODUODENOSCOPY (EGD) TODAY PATIENT ALSO VERBALIZED UNDERSTANDING OF CURRENT MEDICAL SITUATION AND THE NEED TO HAVE AND EGD TODAY FOR REMOVAL OF THE INTERNAL BUMPER. PATIENT WAS TRANSPORTED TO THE ENDOSCOPY DEPARTMENT FOR FOREIGN BODY REMOVAL WITH E

  Patient problems: Foreign Body In Patient

  MAUDE report 9950395 ↗
• InjuryApr 9, 2020Malposition of Device; Malposition of Device

  A REPORT WAS RECEIVED VIA FDA MEDWATCH / FDA USER FACILITY REPORT #: (B)(4) AND THE FOLLOWING INFORMATION WAS PROVIDED: FROM STAFF -PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE PLACEMENT. PER THE OPERATIVE NOTE, THERE WERE NO COMPLICATIONS AND THE PATIENT WAS RETURNED TO THE ICU FOR CARE LATER IN THE EVENING, PATIENT BECAME FEBRILE AND A CHEST X-RAY AND CT OF ABDOMEN WERE COMPLETED. CT OF ABDOMEN REVEALED THE GASTROSTOMY TUBE EXTENDED THROUGH THE ANTERIOR WALL OF THE TRANSVERSE COLON AND FREE AIR AND FLUID IN THE ABDOMEN. THE PATIENT WAS BROUGHT TO THE OR EARLY IN THE MORNING THE FOLLOWING DAY FOR REPAIR OF THE COLON AND REPLACEMENT OF THE PEG TUBE. ORIGINAL INTENDED PROCEDURE: PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE. DATE OF EVENT TIME FRAME NOTED AS (B)(6) 2020.

  Patient problems: Bowel Perforation; Fever; Perforation

  MAUDE report 9946811 ↗

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-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-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-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-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-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-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-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-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-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-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-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