Halyard 94969Recalls & reported problems
Avanos Medical, Inc. · HALYARD* MIC* J Feeding Tube-14-7-10 · 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 10680651949698), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Migration” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Migration1
Patient problems
- Bowel Perforation1
- Obstruction/Occlusion1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 22, 2019Migration; Migration
IT FOLLOWING WAS REPORTED BY THE USER ON A FORM FDA 3500 (10/15): (B)(6) 2018 LAPAROSCOPY PROCEDURE CHANGED INTO LAPAROTOMY AND A GRAHAM PATCH AND JEJUNOSTOMY FEEDING TUBE INSERTED. AFTER SEVERAL DAYS, PATIENT DEVELOPED BILIOUS EMESIS. MD "TOOD" SOME FLUID OUT OF THE BALLOON. ON (B)(6) MD ATTEMPTED TO REMOVE ALL FLUID FROM BALLOON. PT. CONTINUED EMESIS AND AN NG TUBE WAS PLACED. CONTRAST STUDY SHOWED SMALL BOWEL OBSTRUCTION NEAR THE J-TUBE SITE. (B)(6) 2019 - RETURN TO SURGERY, PATIENT HAD EDEMATOUS BOWEL VERY ADHERENT TO ANTERIOR ABDOMINAL WALL AND OTHER PIECES OF BOWEL. IT WAS DIFFICULT TO LOCATE THE LOCATION OF THE J-TUBE. MD PERFORMED LYSIS OF ADHESIONS AND TAKE DOWN OF J-TUBE WITH SMALL BOWEL RESECTION AND PRIMARY HANDSEWN ANASTOMOSIS; REPAIR OF SMALL BOWEL SEROSAL TEAR; REPAIR OF SEROSAL COLON INJURY FROM PREVIOUS OPERATION. OP REPORT STATES THAT MD MADE SURE J-TUBE BALLOON WAS EMPTY PRIOR TO PREP AND DRAPE. SUTURES WERE CUT AND J-TUBE COME OUT WITH SOME RESISTANCE AND FOUND THERE WAS STILL FLUID INSIDE THE BALLOON. MD OPINES THAT THE BALLOON ITSELF WAS THE CAUSE OF THE OBSTRUCTION. REMOVING THE LARGE BALLOON THROUGH THE BOWEL CREATED INJURY. THE BOWEL WAS FULLY MOBILIZED OFF
Patient problems: Bowel Perforation; Obstruction/Occlusion
MAUDE report 8361219 ↗
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- NutraGlide Nasal Feeding Tube ENFT-06090-IApplied Medical Technology, Inc. · Tubes, Gastrointestinal (And Accessories)2 recalls0 reports
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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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