AVANOS 98437Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00350770984377), received between Jun 26, 2020 and Feb 19, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Device Slipped

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2026-00078 FOR THE SECOND EVENT. IT WAS REPORTED THAT DURING THE USE OF AN INTRODUCER KIT DURING A PROCEDURE; WHILE PEELING AWAY THE PEEL AWAY SHEATH, A PART OF THE DILATOR SLIPPED OVER THE GUIDEWIRE AND ENTERED THE PATIENT¿S STOMACH.

  Patient problems: Foreign Body In Patient

  MAUDE report 24392186 ↗
• MalfunctionFeb 19, 2026Device Slipped

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED SIX DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2026-00077 FOR THE FIRST EVENT. IT WAS REPORTED THAT DURING THE USE OF AN INTRODUCER KIT DURING A PROCEDURE; WHILE PEELING AWAY THE PEEL AWAY SHEATH, "THE DILATOR SLIPPED OVER THE GUIDEWIRE DURING REMOVAL OF THE PEEL AWAY SHEATH. FORTUNATELY, THE DOCTOR WAS ABLE TO CATCH THE DILATOR BEFORE IT ENTERED THE STOMACH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392173 ↗
• MalfunctionAug 21, 2023Premature Separation; Premature Separation

  IT WAS REPORTED, ALL THREE T-ANCHORS CAME LOOSE AFTER JUST TWO DAYS OF INSTALLATION. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THERE WAS NO NEED FOR MEDICAL INTERVENTIONS. THE PATIENT¿S STATUS WAS REPORTED TO BE ¿OK, NO PROBLEMS.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17586678 ↗
• MalfunctionSep 15, 2020Break; Break

  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 9611594-2020-00171 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE ANCHOR FELL OFF. THE PATIENT'S CONDITION NOW IS FINE, AND A NEW DEVICE WAS USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537529 ↗
• MalfunctionSep 15, 2020Break; Break

  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 9611594-2020-00172 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE ANCHOR FELL OFF. THE PATIENT'S CONDITION NOW IS FINE, AND A NEW DEVICE WAS USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10537499 ↗
• MalfunctionSep 15, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2020-00180 FOR THE FIRST REPORT. REFER TO 9611594-2020-00181 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE "BUTTON FELL OFF WHEN THE DEVICE WAS APPLIED." THE BUTTON IS THE ANCHOR. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10535382 ↗
• MalfunctionSep 15, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2020-00180 FOR THE FIRST REPORT. REFER TO 9611594-2020-00182 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE "BUTTON FELL OFF WHEN THE DEVICE WAS APPLIED." THE BUTTON IS THE ANCHOR. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10535379 ↗
• MalfunctionSep 15, 2020Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2020-00181 FOR THE SECOND REPORT. REFER TO 9611594-2020-00182 FOR THE THIRD REPORT . IT WAS REPORTED THAT THE "BUTTON FELL OFF WHEN THE DEVICE WAS APPLIED." THE BUTTON IS THE ANCHOR. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10535378 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED "3 T-FASTENERS IN THE KIT ALL BROKE UPON INSERTION." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 11-JUN-2020 STATED, "ALL 3 SUTURES THAT WERE INITIALLY PLACED BROKE WHILE ADVANCING THE SERIAL DILATOR, DISPLACING THE STOMACH AND INTRODUCING A LARGE AMOUNT OF FREE AIR." THE PATIENT HAD A POSITRON EMISSION TOMOGRAPHY (PET) SCAN THE FOLLOWING WEEK WHICH SHOWED A LARGE PNEUMOPERITONEUM, WHICH WAS CAUSING SIGNIFICANT PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10201464 ↗