AVANOS 95644Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00350770956442), received between Dec 18, 2020 and Dec 18, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2020-00248 FOR THE SECOND REPORT. THE PATIENT'S MOTHER REPORTED THAT HER SON HAS BEEN USING GJ [GASTROJEJUNAL] TUBES SINCE 2008. THE 30CM LENGTH IS TOO LONG AND THAT LENGTH HAS LED TO A NUMBER OF PROBLEMS INCLUDING GI BLEEDING (POSITIVE STOOL FOR GUAIAC), CHRONIC ANEMIA REQUIRING IRON INFUSIONS (TUBE RESTS BEYOND AREA OF DUODENUM THAT ABSORBS IRON) AND TENTING OF THE SMALL INTESTINE SEEN ON ENDOSCOPY. CURRENT PHYSICIAN REFUSES TO SHORTEN THE TUBE BY CUTTING THE END. THE PATIENT'S MOTHER ALSO STATED THAT WHERE THE TUBE SITS IN THE SMALL INTESTINE CAUSES HER SON TO HAVE CHRONIC PAIN.

  Patient problems: Anemia; No Code Available; Pain

  MAUDE report 11041830 ↗
• InjuryDec 18, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2020-00247 FOR THE FIRST REPORT. THE PATIENT'S MOTHER REPORTED THAT HER SON HAS BEEN USING GJ [GASTROJEJUNAL] TUBES SINCE 2008. THE 30CM LENGTH IS TOO LONG AND THAT LENGTH HAS LED TO A NUMBER OF PROBLEMS INCLUDING GI BLEEDING (POSITIVE STOOL FOR GUAIAC), CHRONIC ANEMIA REQUIRING IRON INFUSIONS (TUBE RESTS BEYOND AREA OF DUODENUM THAT ABSORBS IRON) AND TENTING OF THE SMALL INTESTINE SEEN ON ENDOSCOPY. CURRENT PHYSICIAN REFUSES TO SHORTEN THE TUBE BY CUTTING THE END. THE PATIENT'S MOTHER ALSO STATED THAT WHERE THE TUBE SITS IN THE SMALL INTESTINE CAUSES HER SON TO HAVE CHRONIC PAIN.

  Patient problems: Anemia; No Code Available; Pain

  MAUDE report 11041796 ↗