Halyard 98606Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20680651986065), received between Oct 2, 2018 and Oct 18, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Excessive Heating” (2 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.

• InjuryOct 18, 2019Grounding Malfunction; Grounding Malfunction

  AN FDA MEDWATCH/ FDA USER FACILITY REPORT # MW 5089607 WAS RECEIVED STATING, "PT WAS ADMITTED FOR RADIO-ABLATION PROCEDURE POST-PROCEDURE THE PT FELT A BURNING PAIN ON THE BACK OF HER KNEE A SMALL BLISTER WAS NOTED IN THE AREA THE INJURY WAS MOST LIKELY DUE TO THE GROUNDING PAD USED DURING THE PROCEDURE POST-DISCHARGE THE PT WENT TO (8)(6) AND IT WAS DETERMINED TO BE A 2ND DEGREE BURN AND TREATED."

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 9210221 ↗
• InjuryJul 16, 2019Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT DURING A RADIO FREQUENCY ABLATION PROCEDURE, THE PATIENT COMPLAINED OF PAIN IN THE RIGHT LEG. AFTER THE PROCEDURE, THE PATIENT'S LEG AND UPPER BACK SIDE OF THE THIGH SHOWED BURNING WOUNDS. WHEN THE PAD WAS REMOVED, THE SITE WAS REDDENED, WITH SEVERAL SMALL BLISTER SITES. THERE WAS NO REPORT OF ANY MEDICAL TREATMENT AT THAT TIME. THE PROCEDURE ITSELF WAS ONLY STOPPED AFTER COMPLETION. THE GROUNDING PAD WAS PLACED IN A VERTICAL POSITION. DURING THE PROCEDURE, THERE WERE NO ERROR MESSAGES ON THE PAIN MANAGEMENT GENERATOR (PMG) AND VALUES OF IMPEDANCES, TEMPERATURE, POWER AND TIME WERE WITHIN THE NORMAL RANGES. ADDITIONAL INFORMATION RECEIVED 17-JUN-2019 STATED THE PATIENT WENT TO THE EMERGENCY DEPARTMENT (ED). THE PATIENT'S BURN WAS TREATED WITH WOUND DRESSINGS AND FLAMAZINE. THE PATIENT WAS ADVISED TO FOLLOW-UP WITH HER GENERAL PRACTITIONER (GP) FOR CHANGE OF WOUND DRESSINGS INSTRUCTIONS. THE PATIENT'S SKIN WAS NOTED DRY DURING THE PROCEDURE. FURTHERMORE, FOUR ABLATIONS WERE PERFORMED, TWO ON EACH SIDE OF THE PATIENT DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED 22-JUN-2019 STATED "THE BURN SITES ARE HEALING NICELY (WOUNDS ARE ENTIRELY COVERED BY FIBRIN W

  Patient problems: Burn, Thermal

  MAUDE report 8796663 ↗
• InjuryFeb 15, 2019Excessive Heating; Excessive Heating

  IT WAS REPORTED THE PATIENT SUSTAINED A SKIN BURN UNDER THE GROUNDING PAD AREA OF THE SKIN. THE PATIENT WAS DIABETIC. THE PATIENT HAD A LEFT THREE LEVEL LUMBAR STANDARD RADIO FREQUENCY ABLATION (SRA) ON (B)(6) 2019. THE GROUNDING PAD WAS PLACED ON THE BACK OF THE UPPER LEFT THIGH. THE PATIENT WAS NOT HAIRY AND THE GROUNDING PAD ADHESION APPEARED NORMAL. THE PROCEDURE PROCEEDED WITHOUT INCIDENT WITH BOTH MOTOR AND SENSORY TESTING, NO HIGH IMPEDANCES NOR WARNINGS ON PAIN MANAGEMENT GENERATOR (PMG). SIX DAYS AFTER THE PROCEDURE THE PATIENT WENT TO THE EMERGENCY ROOM (ER) WITH REPORT OF A BURN AT GROUNDING PAD SITE. THE NURSE REVIEWED THE SKIN AND DESCRIBED THE SKIN AS A FULL THICKNESS CIRCULAR WOUND THE SIZE OF A DIME. IT IS UNKNOWN WHAT TREATMENT WAS DONE IN THE ER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 8345777 ↗
• InjuryOct 2, 2018Grounding Malfunction; Grounding Malfunction

  IT WAS REPORTED THAT DURING THE SECOND BURN THE PAIN MANAGEMENT GENERATOR (PMG) GAVE A TEMPERATURE ERROR MESSAGE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018 STATED THE FIRST ROUND OF ABLATION WAS SUCCESSFUL. THE LOCATION OF THE GROUNDING PAD WAS THE RIGHT FLANK. THE PROCEDURE WAS A LUMBAR RADIO FREQUENCY (RF) ABLATION. AN UNKNOWN ERROR MESSAGE WAS NOTED. THE PHYSICIAN WAS ABLE TO CONTINUE WITH PROCEDURE. DURING THE SECOND BURN, THE PMG GAVE A TEMPERATURE ERROR MESSAGE, EXACT MESSAGE UNKNOWN. STAFF HEARD A "CRACKLING" NOISE AND A BURN WAS NOTICED UNDER PATIENT'S RIGHT FLANK. THE GROUNDING PAD WAS REMOVED FROM THE RIGHT FLANK AND REPLACED WITH A NEW GROUNDING PAD. A SECOND GROUNDING PAD WAS PLACED ON THE UPPER THIGH AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. A WOUND CARE NURSE WAS CONSULTED FOR THE BURN. IT WAS UNKNOWN WHAT SEVERITY OR IF TREATMENT WAS REQUIRED.

  Patient problems: Burn(s)

  MAUDE report 7928124 ↗