MIC PEG TUBE 8180-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00350770006581), received between Dec 27, 2024 and Sep 21, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50844200 ↗
• MalfunctionJul 16, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED "THE PATIENT CAME INTO CLINIC ON MONDAY, JUNE 16 AND THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE WAS REMOVED PER PROPER PROCEDURE. UNFORTUNATELY, THE BUMPER BROKE OFF INSIDE THE PATIENT. THE PATIENT WAS BROUGHT EMERGENTLY TO THE CVOR [CARDIOVASCULAR OPERATING ROOM], WHERE WE PERFORMED AN EGD [ESOPHAGOGASTRODUODENOSCOPY] AND NOTED THE BUMPER HAD ALREADY PASSED THROUGH. WITH A SUBSEQUENT CT [COMPUTED TOMOGRAPHY] SCAN, THE BUMPER WAS FOUND IN THE DISTAL SMALL INTESTINE. [THE CLINICIANS] ARE CLOSELY MONITORING THE PATIENT FOR POTENTIAL ILEOCECAL VALVE OBSTRUCTION OR IF THE PATIENT PASSES THE ITEM." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22524392 ↗
• MalfunctionJun 25, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2025-00016 FOR THE SECOND EVENT. IT WAS REPORTED THE PHYSICIAN WAS INSERTING THE INTRODUCER NEEDLE INTO THE PATIENT, IT BROKE AT THE HUB. THE PHYSICIAN WAS ABLE TO PULL IT OUT WITHOUT COMPLICATION. ADDITIONAL INFORMATION RECEIVED 03-JUN-2025 STATED A NEW KIT WAS UTILIZED. THE PATIENT IS DECEASED. THE PATIENT'S DEATH WAS NOT RELATED TO THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG TUBE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22331023 ↗
• MalfunctionJun 25, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2025-00015 FOR THE FIRST EVENT. IT WAS REPORTED THE PHYSICIAN WAS INSERTING THE INTRODUCER NEEDLE INTO THE PATIENT'S ABDOMEN. THE PATIENT'S ABDOMEN "SUCKED IT IN AND DISAPPEARED INTO THE ABDOMEN." THE PHYSICIAN HAD TO TAKE FORCEPS AND "DIG TO FIND IT" AND PULL IT OUT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY PLACE THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) WITHOUT ANY INJURY AFTER THAT INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22331018 ↗
• MalfunctionMar 27, 2025Failure to Eject; Failure to Eject

  IT WAS REPORTED THE PHYSICIAN NOTES THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUB SEEMS STIFFER AND CANNOT BE EASILY REMOVED VIA TRACTION, SO THE PHYSICIAN REMOVED THE DEVICE ENDOSCOPICALLY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21706794 ↗
• MalfunctionJan 14, 2025Difficult to Remove; Difficult to Remove

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2025-00002 FOR THE FIRST EVENT. IT WAS REPORTED; THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE WAS UNABLE TO BE REMOVED IN OFFICE. UNIDETFIED ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152328 ↗
• MalfunctionJan 14, 2025Difficult to Remove; Difficult to Remove

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2025-00003 FOR THE SECOND EVENT. IT WAS REPORTED WHILE "ATTEMPTING TO REMOVE THE PEG [PERCUTANEOUS ENDOSCOPIC GASTROSTOMY] TUBE VIA TRACTION REMOVAL IN OFFICE. THE PATIENT HAD THEIR PEG IN FOR 7-MONTHS. APP [ADVANCED PRACTICE PROVIDER] WAS UNABLE TO REMOVE PEG TUBE, AND PATIENT WAS SENT FOR EGD [ ENDOSCOPIC DIAGNOSTIC PROCEDURE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152322 ↗
• MalfunctionDec 27, 2024Break; Break

  IT WAS REPORTED THE CLINICIAN "WAS ATTEMPTING TO REMOVE THE PEG (PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE VIA TRACTION REMOVAL IN OFFICE. THE PATIENT HAD THEIR PEG IN FOR A FEW MONTHS. THE PEG TUBE WOULD NOT DISLODGE FROM THE STOMA TRACT AFTER A FEW ATTEMPTS. [THE CLINICIAN] NOTIFIED A GI (GASTROENTEROLOGISTS) PHYSICIAN ON SITE AND HE CAME TO ASSIST. [THE PHYSICIAN] ATTEMPTED TO ALSO PULL THE TUBE OUT OF THE TRACT VIA TRACTION REMOVAL AND IT WAS NOTICED THAT THE INTERNAL BUMPER BROKE OFF FROM THE TUBE. IT REMAINED [INSIDE] THE PATIENT. THE PATIENT HAD TO UNDERGO AN EGD [ESOPHAGOGASTRODUODENOSCOPY], AND IT WAS DETERMINED THE BUMPER BE LEFT TO PASS ON ITS OWN."

  Patient problems: Foreign Body In Patient

  MAUDE report 21029008 ↗

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