AVANOS CRKA-17-100-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193493479061), received between Jun 1, 2023 and Aug 22, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Wrong Label” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Wrong Label; Wrong Label

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2024-00046 FOR THE SECOND EVENT. IT WAS REPORTED, THE 100MM KIT CONTAINED ONE 150MM FLUID DELIVERY INTRODUCER AND ONE 100MM FLUID DELIVERY INTRODUCER. HIGH IMPEDANCE ISSUES OCCURRED DURING THE ABLATION. THE DEVICE WAS CHANGED OUT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032835 ↗
• MalfunctionAug 22, 2024Wrong Label; Wrong Label

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2024-00045 FOR THE FIRST EVENT. IT WAS REPORTED, THE 100MM KIT CONTAINED ONE 150MM FLUID DELIVERY INTRODUCER AND ONE 100MM FLUID DELIVERY INTRODUCER. HIGH IMPEDANCE ISSUES OCCURRED DURING THE ABLATION. THE DEVICE WAS CHANGED OUT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032644 ↗
• MalfunctionJul 23, 2024Wrong Label; Wrong Label

  IT WAS REPORTED, ¿THE PATIENT WAS ON THE TABLE AND THE PHYSICIAN REQUESTED THE KIT BE OPENED. WHEN OPENED AND GIVEN TO THE PHYSICIAN, HE IMMEDIATELY ASKED WHY HE WAS GIVEN A 150MM AND NOT A 100MM. THE NURSES SHOWED HIM THE PACKAGE AND THE LABELING. EVERYTHING WAS LABELED AS A 100MM. HE PROCEEDED AND TRIED TO MAKE IT WORK. THE NEEDLE WAS A 100MM BUT THE PROBE WAS A 150MM. BECAUSE HE WAS NOT ABLE TO REACH THE AREA HE NEEDED, HE ENDED UP OPENING A NEW KIT.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810474 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, A PATIENT WHO HAD A COOLIEF RADIOFREQUENCY LUMBAR (RF) PROCEDURE PERFORMED ON (B)(6) 2023, WAS HOSPITALIZED WITH AN INFECTION. THE PROVIDERS REPORTED THE PATIENT THE PATIENT HAD MULTIPLE COMORBIDITIES AND PRESENTED WITH PAIN TEN DAYS FOLLOWING THE PROCEDURE; THEY WERE DIAGNOSED AND HOSPITALIZED WITH AN EPIDURAL ABSCESS AT THE TREATMENT SITE. IT WAS NOTED THAT NO DIFFICULTIES OR PROBLEMS WERE REPORTED WITH THE RF EQUIPMENT DURING THE CASE, ¿EVERYTHING WENT SMOOTHLY¿. ADDITIONALLY, THE PROVIDERS WERE NOT MAKING ANY ASSUMPTIONS OR ACCUSATIONS ABOUT THE CAUSE OF THE POST-PROCEDURE INFECTION. ADDITIONAL INFORMATION RECEIVED 15MAY2023, THE PATIENT HAD BEEN HOSPITALIZED FOR SEVEN DAY AND WAS DIAGNOSED WITH STREP GALLOLYTICUS BACTERIA, A GASTROINTESTINAL (GI) BACTERIUM, WHICH WAS TREATED WITH FOUR (4) BROAD SPECTRUM ANTIBIOTICS. NEXT DIAGNOSTIC STEP NOTED TO BE A COLONOSCOPY; THE PATIENT WAS EXPECTED TO REMAIN HOSPITALIZED UNTIL THE (B)(6) 2023 (WEEKS END).

  Patient problems: Abscess; Bacterial Infection; Pain

  MAUDE report 17043491 ↗