AVANOS 44101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770441016), received between Aug 6, 2020 and Jul 11, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Complete Blockage; Material Rupture; Complete Blockage; Material Rupture

  IT WAS REPORTED, BOTH THE JEJUNAL AND GASTRIC PORTS LEAD TO CONTRAST FLOWING IN THE STOMACH AND NO FLOW DEMONSTRATED WITHIN THE JEJUNOSTOMY TUBING. SEQUENCE OF EVENTS: ON (B)(6) 2025: REVISION OF MIKEY GJ [GASTROJ-EJUNAL] TUBE (B)(6) 2025: MILKY CONTENT IN GASTROSTOMY ¿ WHEN ONLY JEJOSTOMY WAS USED ¿ CLINICALLY FELT THE JEJOSTOMY WAS DISPLACED. ON (B)(6) 2025: PATIENT CONCERNED THAT THE TUBE IS BROKEN IN THE SAME WAY AS PREVIOUS TUBE. ON FLUSHING A SMALL POP WAS HEARD AND THEN TUBE WAS EASIER TO FLUSH, ANY BLOCKAGE THOUGHT PRESENT WAS NOW CLEAR. ON (B)(6) 2025: SINOGRAM CONFIRMED THE JEJOSTOMY IS IN STOMACH. BOTH THE JEJUNAL & GASTRIC PORTS LEAD TO CONTRAST FLOWING IN THE STOMACH AND NO FLOW DEMONSTRATED WITHIN THE JEJOSTOMY TUBING. ON (B)(6) 2025: GJ TUBE REMOVED BY MYSELF. ADDITIONAL INFORMATION RECEIVED 19-JUN-2025 STATING, "PATIENT HAD INCREASED VOMITING ON DAY OF ¿FEELING THE TUBE HAD BECOME DISLODGED LIKE LAST TIME¿ PATIENT REFUSED FOR TUBE TO BE USED. FEED HELD OFF SO UNABLE TO GIVE PATIENT NUTRITIONAL SUPPORT AND NEEDED IV [INTRAVENOUS] FLUIDS STARTED." THE PATIENT IS CURRENTLY WELL AND ATTENDING THE WARD TWICE WEEKLY FOR IV FLUIDS AND WEANING OFF ENTERAL FEEDS AT HOME. THE

  Patient problems: Vomiting

  MAUDE report 22487017 ↗
• MalfunctionOct 25, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS INITIALLY REPORTED ON (B)(6) 2023, THE TUBE HAS SPLIT BELOW THE BALLOON. "WHEN COMPLETING A TUBE CHANGE IN RADIOLOGY, LOSS OF CONTRAST NOTED AND LEAKAGE BACK TOWARDS THE GUT. ON REMOVAL, LARGE SPLIT NOTED ON THE TUBE." BASED ON SAMPLE EVALUATION INITIATED ON 03OCT2023 (REGULATORY ALERT DATE), THE EVALUATION CONFIRMS THAT THE DAMAGE TO THE TUBING ALLOWED CROSS-COMMUNICATION BETWEEN THE GASTRIC AND JEJUNAL LUMENS.

  Patient problems: Insufficient Information

  MAUDE report 18007872 ↗
• MalfunctionAug 6, 2020Complete Blockage; Material Split, Cut or Torn; Complete Blockage; Material Split, Cut or Torn

  IT WAS REPORTED THAT "MEDICATION WAS NOTED IN STOMACH." ADDITIONAL INFORMATION RECEIVED 22-JUL-2020 INDICATED THE MEDICATION WAS ADMINISTERED VIA THE JEJUNAL PORT. ADDITIONAL INFORMATION RECEIVED 04-AUG-2020 INDICATED THE DEVICE WAS IN PLACE FOR 21 DAYS. THERE WAS NO PATIENT INJURY. THE DEVICE WAS "CHANGED RADIOLOGICALLY BY CONSULTANT SURGEON." VARIOUS MEDICATIONS WERE ADMINISTERED VIA THE JEJUNAL PORT. THE BALLOON WAS INFLATED WITH 5ML OF "COOLED BOILED WATER." INFORMATION WAS NOT PROVIDED REGARDING THE CLEANING SOLUTIONS OR MATERIALS USED IN ASSOCIATION WITH THE PRODUCT. PER INFORMATION PROVIDED BY THE DISTRIBUTOR, THE JEJUNAL LUMEN WAS UNABLE TO BE FLUSHED PAST THE AREA OF THE GASTRIC OUTLETS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10374809 ↗