AVANOS 46932Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193493469321), received between Jan 19, 2021 and Dec 5, 2023 — classified as 2 injuries.

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.

• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN USED THE COOLIE KIT TO PERFORM A HIP COOLIEF RF ABLATION. "AFTER TREATMENT FOR 2:30 MINUTES, AND UPON FINALIZING THE CASE [THE PHYSICIAN] FACED A BLEEDING FROM THE OBTURATOR CANULA INTRODUCTORY POSITION. [THE PHYSICIAN] REMOVED THE CANULA AND APPLIED PRESSURE FOR 5 MINUTES UNTIL HEMOSTASIS WAS ACHIEVED. [ABOUT] 3-4 DAYS POST-OP PATIENT SUFFERED A SEVERE PAIN NEAR THE FEMORAL ARTERY AND WAS TAKEN TO HOSPITAL, AFTER EXAMINATION AND SCANS, 2 ANEURYSMS. PATIENT RECEIVED HOSPITALIZED TREATMENT FOR A FEW DAYS TO TREAT ANEURYSMS AND STABILIZE PATIENT AND PREVENT FURTHER COMPLICATION. UPON INVESTIGATION IT WAS FOUND THAT PATIENT HAD A CARDIOVASCULAR VALVE OPERATION AND HAS BEEN ON WARFARIN FOR A LONG TIME. BEFORE THE COOLIEF PROCEDURE, WARFARIN WAS CEASED, AND PATIENT WAS PLACED ON CLEXANE INJECTIONS INSTEAD. PATIENT RESUMED WARFARIN TREATMENT THE DAY AFTER COOLIEF PROCEDURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18267903 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA A PHYSICIAN THAT A PATIENT HAS EXPERIENCED A MOTOR DEFICIT FOLLOWING A COOLED RF PROCEDURE THAT WAS PERFORMED ON (B)(6) 2020. THE PHYSICIAN NOTED THAT ALL ASPECTS OF THE PROCEDURE WENT AS EXPECTED AND ALL EQUIPMENT HAD PERFORMED WITHOUT INCIDENT. PER ADDITIONAL INFORMATION RECEIVED 5 JAN 2021, THE PHYSICIAN IS IN A PRIVATE PRACTICE AND DOES NOT DO COOLED RF PROCEDURES AT THEIR OFFICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11195812 ↗