Halyard 44075Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651440751), received between Nov 2, 2017 and Nov 2, 2017 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN PERFORMED A COOL RADIO FREQUENCY OF THE KNEE AND STATED THE PATIENT HAD A SUBCUTANEOUS WOUND WHERE HE PERFORMED LESIONING THE INFERIOR GENICULAR NERVE. ADDITIONAL INFORMATION WAS PROVIDED ON THE SAME DAY THAT STATES THE REPRESENTATIVE AND THE CLINICAL EDUCATOR WERE PRESENT DURING THE CASE. HE STATED THE GENERATOR USED WAS HIS OWN AND HE WOULD EMAIL THE PROBE INFORMATION. THE GROUNDING PAD USED WAS A HALYARD PAD. A CALL WAS RECEIVED FROM THE PHYSICIAN WHO STATED THE DEVICE DID NOT EXHIBIT ANY ALERTS OR ERROR MESSAGES. THE PHYSICIAN WAS UNABLE TO QUANTIFY IF THE BURN WAS A 1ST, 2ND,OR 3RD DEGREE BURN. HE STATED HE IS NO LONGER FOLLOWING THE PATIENT. THE PATIENT IS CURRENTLY USING SILVADENE ON THE WOUND AND HAS NOT REPORTED RECEIVING FURTHER TREATMENT FOR THE WOUND CURRENTLY. THE PATIENT IS SEEKING A PLASTIC SURGEON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Burn(s)

  MAUDE report 6996715 ↗

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