Cool-tipRecalls & reported problems across all models
Covidien LP · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 145
- Deaths reported
- 1
- Injuries reported
- 29
- Recalls
- 0
We found 16 models of Cool-tip by Covidien LP in the FDA's device registry (GUDID). Together they are named in 145 adverse event reports in the FDA's MAUDE database, received between Apr 15, 2016 and Apr 14, 2026 — classified as 1 death, 29 injuries, 115 malfunctions.
The most frequently reported specific device problem is “Temperature Problem” (64 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Cool-tip problems
Device problems
- Temperature Problem64
- No Flow33
- Adverse Event Without Identified Device or Use Problem21
- Appropriate Device Problem Term/Code Not Available10
- Break8
- Device Alarm System7
- Peeled/Delaminated7
- Failure to Fire6
Patient problems
- No Consequences Or Impact To Patient52
- No Clinical Signs, Symptoms or Conditions24
- No Known Impact Or Consequence To Patient19
- No Patient Involvement17
- No Code Available14
- Insufficient Information9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Burn(s)3
Cool-tip models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cool-tip ACT2030ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES55 reports
- Cool-tip ACT2020ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES30 reports
- Cool-tip ACT1530ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES14 reports
- Cool-tip ACT1520ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES13 reports
- Cool-tip ACT1510ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Cool-tip ACTC1525ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- Cool-tip ACTC2025ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Cool-tip ACT2530ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Cool-tip CTRF 220ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES4 reports
- Cool-tip CTRF 100ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
- Cool-tip ACT1507ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Cool-tip DGP-HPELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES2 reports
- Cool-tip RFASWSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 death1 report
- Cool-tip ACT1030ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Cool-tip SWCT1530ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Cool-tip CTRF 117ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Recent Cool-tip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 14, 2026No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS NOT ABLE TO BE COMPLETED AND WAS ABORTED DUE TO THE DEVICE FAILED TO CIRCULATE.
Patient problems: Insufficient Information
MAUDE report 24872964 ↗InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE THE DEVICE'S FAILURE TO CIRCULATE.
Patient problems: Insufficient Information
MAUDE report 24730090 ↗InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE FAILED TO CIRCULATE, RESULTING IN THE PROCEDURE BEING ABORTED.
Patient problems: Insufficient Information
MAUDE report 24729873 ↗InjuryMar 30, 2026No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE DEVICE'S FAILURE TO CIRCULATE.
Patient problems: Insufficient Information
MAUDE report 24729826 ↗InjuryJan 16, 2026No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO THE WATER TEMPERATURE WAS NOT RISING.
Patient problems: Insufficient Information
MAUDE report 24094322 ↗InjuryDec 22, 2025Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE BROKE RESULTING IN THE PROCEDURE BEING ABORTED.
Patient problems: Insufficient Information
MAUDE report 23863139 ↗InjuryDec 22, 2025Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output; Device Alarm System; Appropriate Device Problem Term/Code Not Available; Intermittent Energy Output
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO TEMPERATURE ISSUE, SPECIFICALLY ABNORMAL WATER TEMPERATURE THAT EXCEEDED 99°C, WHICH TRIGGERED AN AUTOMATIC SHUTDOWN.
Patient problems: Insufficient Information
MAUDE report 23861778 ↗InjuryNov 18, 2025No Flow; Appropriate Device Problem Term/Code Not Available; No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO FAILURE TO CIRCULATE.
Patient problems: Insufficient Information
MAUDE report 23584234 ↗InjuryNov 18, 2025No Flow; Appropriate Device Problem Term/Code Not Available; No Flow; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO A CIRCULATION ISSUE, SPECIFICALLY A FAILURE TO CIRCULATE.
Patient problems: Insufficient Information
MAUDE report 23584183 ↗MalfunctionNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A PERCUTANEOUS VENTRICULAR SEPTAL MYOCARDIAL ABLATION, A PATIENT SUSTAINED TWO FIRST-DEGREE SKIN BURNS, EACH APPROXIMATELY 13 BY 7 CM ON THE LOWER RIGHT ABDOMEN. THE BURNS WERE ATTRIBUTED TO HEAT CONDUCTION FROM THE PRODUCT. FOLLOWING THE PROCEDURE, THE PATIENT RECEIVED WOUND DRESSING TREATMENT AND CONSULTATIONS WERE CONDUCTED WITH THE DERMATOLOGY DEPARTMENT, PLASTIC AND COSMETIC SURGERY DEPARTMENT AND THE WOUND AND STOMA CLINIC.
Patient problems: Superficial (First Degree) Burn
MAUDE report 23450819 ↗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 ↗InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO LITERATURE SOURCE OF RETROSPECTIVE STUDY PERFORMED BETWEEN FEBRUARY 2013 AND MAY 2021, THE LONG-TERM OUTCOMES OF RFA USING COOL-TIP RFA FOR PERIBILIARY AND NON-PERIBILIARY HCC USING PROPENSITY SCORE MATCHING (PSM), 282 PATIENTS WERE INCLUDED IN THIS RETROSPECTIVE STUDY. COMPLICATIONS INCLUDED INTRAHEPATIC BILE DUCT DILATATION (18), BILOMA FORMATION (1), BILIARY FISTULA (1), LIVER DECOMPENSATION (55), THROMBUS IN PERITUMORAL VESSEL (10), PAIN REQUIRING TREATMENT (19), INFECTION (14), HYDROPNEUMOTHORAX REQUIRING DRAINAGE (3). BILOMA FORMATION AND BILIARY FISTULA WERE TREATED WITH PERCUTANEOUS BILIARY DRAINAGE.
Patient problems: Biliary Leak; Fistula; Liver Damage/Dysfunction; Pain; Pneumothorax; Thrombosis/Thrombus; Unspecified Infection
MAUDE report 22293714 ↗MalfunctionJun 3, 2025No Flow; No Flow
IT WAS REPORTED THAT THE DEVICE FAILED TO CIRCULATE DURING THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW DEVICE. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22131635 ↗MalfunctionAug 28, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE CONSUMABLE COULD NOT BE WATER CIRCULATED AND THE ABLATION NEEDLE OVERHEATED. THE PHYSICIAN REPLACED THE DEVICE AND CONTINUED THE SURGERY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20090654 ↗DeathMay 17, 2024Device Alarm System; Appropriate Device Problem Term/Code Not Available; Device Alarm System; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE GENERATOR ALARMS SOUNDED AND IT DID NOT REACH THE TEMPERATURE. THE PROCEDURE WAS ABORTED-PATIENT UNDER ANESTHESIA AND COULD NOT BE PERFORMED BECAUSE THE PATIENT WAS BLEEDING. SURGEON CAUTERIZE THE BLEEDING. PATIENT WAS ADMITTED TO INTENSIVE CARE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19342992 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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