AVANOS 98704Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770987040), received between Jun 11, 2021 and Aug 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Break; Break

  IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5101910 THE FOLLOWING INFORMATION WAS PROVIDED: "TELESCOPING DILATORS BECAME RETAINED FOREIGN BODIES IN THE STOMACH THE LARGEST DILATOR KINKED THEREBY INCREASING RESISTANCE ON THE INTERMEDIATE SIZED DILATORS WHICH WERE NOT PULLED OUT BY THE SMALLEST DILATOR DILATORS WERE REMOVED BY EGD AFTER PRESENTATION TO THE HOSPITAL AFTER EVENTUAL REMOVAL OF THE GASTROSTOMY TUBE FDA SAFETY REPORT ID# (8)(4)." ADDITIONAL INFORMATION NOTES THE PATIENT PRESENTED TO EMERGENCY ROOM (ER) WITH ABDOMINAL PAIN. THE PATIENT WAS DISCHARGED UNEVENTFULLY AFTER ENDOSCOPIC RETRIEVAL OF RETAINED DILATORS WITH SOME MUCOSAL IRRITATION WITHOUT ADDITIONAL INJURIES

  Patient problems: Foreign Body In Patient

  MAUDE report 12285419 ↗
• MalfunctionJun 11, 2021Separation Problem; Separation Problem

  IT WAS REPORTED THE "DILATOR CAME APART FROM THE DEVICE AND HAD TO BE RETRIEVED FROM THE PATIENT WITH A HEMOSTAT." "DURING THE PROCEDURE THE INITIAL TUBE [SLID] WITHIN THE SERIAL DILATOR [AND] APPEARED TO BE LOST." THE CLINICIANS HAD AN ISSUE WITH THE LAST SLIDE OF THE DEVICE AND PUSHED IT IN TOO FAR AND HAD TO PULL IT OUT WITH A HEMOSTAT. UPON RETRIEVAL THEY COULDN'T FIND THE INITIAL TUBE SLIDE. THE PHYSICIAN THOUGHT IT MIGHT HAVE BEEN LOST IN THE PATIENT. HOWEVER, THE SCAN CAME BACK NEGATIVE AND THE PATIENT IS FINE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11984538 ↗