AVANOS CRK-17-50-4Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193493440757), received between Dec 27, 2019 and Sep 10, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K053082); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2020Break; Break

  IT WAS REPORTED THE INTRODUCER PROBE COMPLETELY BROKE DURING USE. "THERE WAS NO PATIENT INJURY AND THE PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT, ALTHOUGH ANOTHER CRK KIT HAD TO BE OPENED TO GET A NEW INTRODUCER." [THE] "INTRODUCER WAS ONLY USED ONCE (MEDICAL ASPECT). WHEN THE PHYSICIAN STARTED TO MOVE THE NEEDLE, THE END BROKE OFF. THE NEEDLE WAS ENGAGED IN THE SKIN AND THERE WAS NO HARDWARE IN THIS PATIENT. ADDITIONAL INFORMATION RECEIVED ON 18-AUG2020 STATED WHEN DOCTOR WAS ASKED IF STYLET WAS IN PLACE WHEN HE WAS MOVING THE INTRODUCER, AND IT BROKE, HIS RESPONSE WAS "MAYBE NOT." NO ADDITIONAL INFORMATION AS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10515546 ↗
• MalfunctionFeb 6, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT PT [PATIENT] WAS UNDERGOING KNEE COOLED RF [RADIOFREQUENCY] PROCEDURE. DURING THE THIRD BURN AT THE INFERIOR SITE, THE PATIENT SUSTAINED A BURN. IT WAS NOTICED WHEN INTRODUCER WAS REMOVED THAT THE INSULATION HAD BECOME DISCONNECTED FROM THE INTRODUCER SHAFT AND HAD EXPOSED MUCH OF THE SHAFT AND THE INSULATION WAS PUSHED UP THE SHAFT. PT SUSTAINED A "CRATER-LIKE" BURN AT THE SITE. PT WAS SENT TO THE WOUND CENTER FOR TREATMENT AND FOLLOW-UP. PRODUCT RETAINED BY USER FACILITY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PHYSICIAN THE SAME DAY AND IS AS FOLLOWS: "THERE WAS NOTHING ABNORMAL ABOUT PLACEMENT OF THE PROBE. THE SKIN WAS NORMAL, NO BONE ENCOUNTERED, VERY EASY PLACEMENT. PRIOR TO INSERT, I NOTICED THE MARKING WAS A LITTLE OFF ON THE LINES (SPACING NOT EXACT) AND THERE WAS A TINY BIT OF TEXTURE IRREGULARITY (VERY MINOR) BUT DIDN'T THINK MUCH OF IT DUE TO PRODUCT VARIABILITY WE SOMETIMES SEE. NOTHING ELSE SEEMED OUT OF THE ORDINARY. IN RETROSPECT, HAD I KNOWN THERE COULD HAVE BEEN A CONDUCTION/INSULATION ISSUE I WOULD HAVE PAID MORE ATTENTION TO THOSE IRREGULARITIES. I WAS WATCHING THE PROBE THE WHOLE TIME AND THE PATIENT REPORTED SOME "BURNING" FEELING -

  Patient problems: Burn(s)

  MAUDE report 9677902 ↗
• InjuryDec 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PHYSICIAN PERFORMED A GENICULAR COOLIEF RADIO FREQUENCY ABLATION (RFA) POST TOTAL KNEE AMPUTATION (TKA) PATIENT ON (B)(6) 2019. A MINIMAL AMOUNT OF FLUID WAS ASPIRATED FROM ONE OF THE INTRODUCER SITES. PRIOR TO INJECTION OF LIDOCAINE AND LESIONING, THE PHYSICIAN TRIED TO ASPIRATE THE TARGET AGAIN AND HAD NO FLUID RETURN. LESIONING WAS THEN PERFORMED "FOR THE 2:30" WITH NO ISSUES WITH IMPEDANCE, TEMPERATURE OR GENERATOR ALARMS. THE PATIENT WAS SEEN FOR A FOLLOW-UP ON 03-DEC-2019 AND REPORTED INCREASED PAIN IN THE KNEE. UPON EXAMINATION, THE PHYSICIAN NOTICED REDDENING OF THE SKIN AROUND THAT SITE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND A FLUID SPECIMEN WAS OBTAINED AND TESTED. IT REVEALED NO SIGNS OF INFECTION AS NOTED BY THE PHYSICIAN. ADDITIONAL INFORMATION RECEIVED 06-DEC-2019 STATE THE PATIENT WAS TREATED WITH A MEDROL DOSE PACK AND VANCOMYCIN.

  Patient problems: Pain; Swelling

  MAUDE report 9528259 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K053082. One submission often covers many models, so check the product and lot details in each record.

• Z-2391-2016 · Jun 16, 2016 · Terminated
  Coolife Sinergy Radiofrequency Kit, SIK-17-75-4 (109971504); Kit used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
• Z-1755-2010 · May 12, 2010 · Terminated
  The Baylis LumbarCool Pain Management Kit consisting of: 1 LumbarCool Pain Management Probe, 3 LumbarCool Pain Management introducers, and 1 Pain Management Tube Kit. Model/Catalo