Cool-tip CTRF 117Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884524001548), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K973297); 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.

• MalfunctionJun 18, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD IMPEDANCE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7611392 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K973297. 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