Cool-tip ACT1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884524001173), received between Jun 6, 2017 and Jul 28, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2020No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING THYROID ABLATION, THE DEVICE HAD A CIRCULATION PROBLEM WHEREIN IT WAS UNABLE TO LOOP. WHILE THE PATIENT WAS ANESTHETIZED, THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available

  MAUDE report 10335582 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output; Adverse Event Without Identified Device or Use Problem; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING THYROID NODULE SURGERY, THE DEVICE HAD INTERMITTENT ACTIVATION. IT WAS NOTED THAT THE ISSUE WAS A PROBLEM WITH THE GENERATOR. THE PROCEDURE WAS ABORTED AND THE PATIENT WAS UNDER GENERAL ANESTHESIA AND THE PROCEDURE WAS RESCHEDULED.

  Patient problems: No Code Available

  MAUDE report 10304359 ↗
• MalfunctionDec 19, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, AFTER THE PUNCTURE WAS COMPLETED, THE IMPEDANCE IS TOO HIGH AND IT STOPS WORKING AFTER TWO OR THREE SECONDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182126 ↗
• MalfunctionDec 18, 2018Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, DURING USE, THE UNIT HAD HIGH IMPEDANCE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8173548 ↗
• MalfunctionJun 6, 2017Temperature Problem; Temperature Problem

  THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE ELECTRODE WOULD NO LONGER MEASURE TEMPERATURE. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WILL BE MADE AVAILABLE BY THE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6616465 ↗