Cool-tip RFASWRecalls & reported problems
Covidien LP · Ablation Footswitch · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521048720), received between May 17, 2024 and May 17, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Device Alarm System” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Device Alarm System1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
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 ↗
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- Emprint CA30L2Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES2 recalls2 reports
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- NEUWAVE PR15XTNeuwave Medical, Inc. · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES90 reports
- Emprint CA20L1Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 recall18 reports
- Emprint CA30L1Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 recall1 death9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.