AVANOS 44562Recalls & reported problems
Avanos Medical, Inc. · * MIC* Bolus Gastrostomy Feeding Tube with ENFit® Connector · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00350770445625), received between Oct 24, 2025 and Oct 24, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Deflation Problem” (1 report).
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
- Deflation Problem1
Patient problems
- Abdominal Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 24, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED PATIENT HAD A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) INSERTED ON THE (B)(6) 2025, PATIENT COMPLAINED TO SEVERE ABDOMINAL PAIN AROUND NOON TIME ON THE (B)(6) 2025. GASTROSTOMY FEEDING TUBE WAS SLIGHTLY DISLODGED... [COMPUTED TOMOGRAPHY] CT SCAN WAS DONE AND CONFIRMED ABDOMINAL LEAK OF STOMACH FLUIDS IN BETWEEN THE MUSCLE OF THE ABDOMINAL WALL. A NEW AVANOS MIC BOLUS 18FG GASTROSTOMY FEEDING TUBE WAS INSERTED, BALLOON INFLATED WITH 8ML CONTRAST/SALINE. PREVIOUS AVANOS MIC BOLUS 18FG GASTROSTOMY FEEDING TUBE WAS KEPT ON THE STERILE SET UP AND [THE PHYSICIAN], TESTED THE BALLOON AND INJECTED SALINE AND EVIDENT 'TEAR' WAS VISIBLE AS SALINE JUST LEAKED IMMEDIATELY." PATIENT "COMPLAINED OF PAIN AND FELT UNWELL, RISK OF INFLAMMATION/INFECTION, REPEATED PROCEDURE WAS REQUIRED INCLUDING ADDITIONAL RADIATION DOSE AND MEDICAL INTERVENTION REQUIRED RIG EXCHANGE REPEATED PROCEDURE, [INTRAVENOUS ANTIBIOTICS] MONITORING, CURRENT PATIENT STATUS REPORTED AS WELL." ADDITIONAL INFORMATION RECEIVED 13-OCT-2025 STATED NO "FURTHER INFORMATION ON THE PATIENT DEMOGRAPHICS" WAS AVAILABLE.
Patient problems: Abdominal Pain
MAUDE report 23384092 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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