Halyard 42748Recalls & reported problems
Avanos Medical, Inc. · MIC-KEY G, ISO, KIT, 16FRX2.5CM · Class 2 · Implant
All models of Halyard (232)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651427486), received between May 11, 2017 and May 11, 2017 — classified as 1 injury.
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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Dyspnea1
- Pneumonia1
- Sepsis1
- Skin Inflammation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED A NEW PEG TUBE IN THE BEGINNING OF 2017 THAT THEY HAD NEVER USED BEFORE. AFTER THE PLACEMENT OF THIS PEG, THE PATIENT ALLEGES THAT AN ALLERGIC REACTION BEGAN OUTSIDE OF THE STOMACH, IN THE FORM OF WOUNDS, WHICH THE PATIENT TREATED THEMSELVES. AFTER THAT, THE PATIENT ALLEGES STOMACH FLU LIKE SYMPTOMS AND INCREASING WEAKNESS, WITH DIFFICULTY BREATHING, EVEN ON RESPIRATOR. THE PATIENT WENT TO THE HOSPITAL WHERE THE PATIENT ALLEGES THEY WERE DIAGNOSED WITH SEPSIS AND PNEUMONIA. ON THE ADVICE OF THE HOSPITAL PHYSICIAN, THE PEG TUBE WAS SWITCHED OUT WITH A TYPE THAT THE PATIENT HAD USED BEFORE, UPON WHICH THE PATIENT ALLEGES THAT ALL SYMPTOMS RESOLVED. THE PATIENT REPORTED THAT THEY HAVE COMPLETELY RECUPERATED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.
Patient problems: Dyspnea; Pneumonia; Sepsis; Skin Inflammation
MAUDE report 6559514 ↗
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- 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
- 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
- NutraGlide Nasal Feeding Tube ENFT-06055-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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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