Cool-tip ACT2530Recalls & reported problems
Covidien LP · RFA Single Electrode Kit · Class 2
All models of Cool-tip (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884524001234), received between Feb 27, 2018 and Aug 15, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “No Flow” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- No Flow2
- Break1
- Detachment of Device or Device Component1
- Failure to Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025No Flow; No Flow
IT WAS REPORTED THAT DURING ABLATION, THE DEVICE FAILED TO CIRCULATE. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22815711 ↗MalfunctionJan 27, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING RADIOFREQUENCY ABLATION OF LIVER TUMOR, THE RADIO FREQUENCY NEEDLE WAS BROKEN AND NO PARTS WERE COMPLETELY DETACHED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13363985 ↗MalfunctionFeb 12, 2019No Flow; No Flow
ACCORDING TO THE REPORTER, THE HEALTHCARE TEAM COMPLETED THE TEST BUT IN THE ABLATION PROCEDURE, THE COOLING SYSTEM WAS BLOCKED, THE WATER WAS SLOW TO MOVE IN THE WATER LINE. A NEW DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8331675 ↗MalfunctionFeb 27, 2018Failure to Fire; Failure to Fire
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE ELECTRODE TEMPERATURE HAD NO FUNCTION. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7300810 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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