AVANOS 95675Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770956756), received between Nov 16, 2020 and Nov 18, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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. How this data works · Data updated Oct 13, 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 · 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.

• MalfunctionNov 18, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ONE DEVICE HAD A SMALL HOLE JUST BELOW THE BALLOON SO WHEN FEEDING IN JEJUNAL PORT IT CAME OUT G-PORT. ADDITIONAL INFORMATION RECEIVED 27-OCT-2020 STATED THE PATIENT WAS EXPERIENCING PERSISTENT VOMITING AFTER TUBE FEEDING. AN INTERNAL BREAKAGE FOUND ALLOWING CONTRAST IN JEJUNAL PORT TO LEAK INTO THE GASTRIC SIDE OF THE DEVICE. A NEW TUBE WAS PLACED. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED THE FOLLOWING DAY FOR NAUSEA AND VOMITING. THE TUBE APPEARED IN THE PROPER POSITION.

  Patient problems: Nausea; Vomiting

  MAUDE report 10864384 ↗
• MalfunctionNov 18, 2020Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED ONE DEVICE HAD A SMALL HOLE JUST BELOW THE BALLOON SO WHEN FEEDING IN JEJUNAL PORT IT CAME OUT G-PORT. ADDITIONAL INFORMATION RECEIVED 27-OCT-2020 STATED THE PATIENT WAS VOMITING WITH TUBE FEEDINGS. A KIDNEYS, URETHRA AND BLADDER (KUB) X-RAY NOTED THE DEVICE WAS IN PROPER PLACEMENT. THE DEVICE WAS REPLACED. THE REMOVED DEVICE NOTED A CLOGGED SMALL PIN HOLE BELOW THE BALLOON ON THE JEJUNAL SIDE OF THE DEVICE.

  Patient problems: Vomiting

  MAUDE report 10864184 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED TUBE COMPLETELY BROKEN OFF INSIDE OF THE PATIENT. THE PATIENT HAD TO GO TO ENDOSCOPY AND THE GASTRO-INTESTINAL (GI) DOCTOR PERFORMED A PROCEDURE AND RETRIEVED THE BROKEN DEVICE. ADDITIONAL INFORMATION RECEIVED 27-OCT-2020 STATED THE PATIENT'S MOTHER, A REGISTERED NURSE, REPORTED THE DEVICES HAD A MALFUNCTIONING GASTRIC PORT, WITH REFLUX. THE PATIENT'S MOTHER HEARD A POPPING NOISE WHILE INJECTING INTO THE TUBE ON THE PRIOR EVENING. A WIRE WAS INSERTED, AND THE BUTTON PORTION OF THE DEVICE WAS REMOVED. AT THE TIME OF THE EVENT THE TUBE TRANSECTED, APPROXIMATELY 35CM FROM THE PROXIMAL DUODENUM TO THE JEJUNUM. THE WIRE LEFT IN PLACE, THE WAS PATIENT TRANSFERRED TO ENDOSCOPY FOR RETRIEVAL OF DISTAL PORTION OF TUBE. THE PATIENT WAS RETURNED TO IMAGING AND NEW DEVICE WAS PLACED.

  Patient problems: Foreign Body Sensation in Eye

  MAUDE report 10845205 ↗