Cool-tip DGP-HPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524001296), received between Feb 9, 2021 and Apr 3, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 other recall cover devices cleared under the same FDA submission (K030697); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE SURFACE OF THE RETURN ELECTRODE PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16668649 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING ABLATION ON THE LIVER, THE PATIENT HAD THIRD DEGREE BURN ON THE ANTERIOR SURFACE OF THE LEFT THIGH, WITH 10 X 5, 8 X 3 CM IN SIZE, WHERE THE RETURN ELECTRODES WAS PLACED FULLY IN CONTACT WITH PATIENT'S SKIN. TWO (2) RETURN ELECTRODES WERE USED. PRIOR TO APPLYING THE GROUNDING PAD, THE PATIENT'S SKIN WAS NOT SHAVED, CLEANED, AND DRIED. NO ADDITIONAL ELECTRODE GEL APPLIED TO THE GROUNDING PAD. NO MASSAGE WAS PERFORMED AFTER APPLICATION BUT PAD ADHERED FIRMLY. BOTH PADS WERE NOT TOUCHING EACH OTHER WHEN APPLIED TO THE PATIENT¿S LEFT LOWER EXTREMITY. COOLING, WASHING, DISINFECTION, APPLICATION/CHANGE OF SKIN PROTECTANT(DUOACTIVE AD, HYDROSITE ET) WAS DONE TO TREAT THE BURN SITE. BURN WAS IMPROVED WITH THE CURRENT TREATMENT.

  Patient problems: Burn(s); Full thickness (Third Degree) Burn

  MAUDE report 11301293 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K030697. One submission often covers many models, so check the product and lot details in each record.

• Z-2301-2012 · Aug 1, 2012 · Terminated
  DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surg