Emprint SX CASYS100Recalls & reported problems
Covidien LP · Ablation Platform with Thermosphere Technology · Class 2
All models of Emprint SX (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521703209), received between Jan 20, 2021 and Jan 20, 2021 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
- Unintended Radiation Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, ALL SEEMED TO GO WELL IN THE ABLATION PROCEDURE BUT THE PATIENT COMPLAINED OF PAIN A FEW DAYS AFTER. DUE TO THIS COMPLAINT, A COMPUTED TOMOGRAPHY (CT) WITH CONTRAST WAS REQUIRED, THEY FOUND THAT THE ABLATION ZONE LARGER THAN ANTICIPATED AT 57MM*47MM*68MM. A FOLLOW UP CONTRAST CT WILL BE DONE AROUND THE 30 DAY MARK. THE PATIENT HAD A SEVERE BLADDER INFECTION (PUSS FILLED BLADDER) AND EXPIRED DUE TO THIS CONDITION.
Patient problems: Pain; Unintended Radiation Exposure
MAUDE report 11205765 ↗
Other SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES devices
- Emprint CA20L2Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES2 recalls1 death43 reports
- Emprint CA15L2Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES2 recalls1 death41 reports
- Emprint CA30L2Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES2 recalls2 reports
- Emprint CA15L1Covidien LP · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 recall49 reports
- Solero 700106001-USAngiodynamics, Inc. · SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES92 reports
- 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 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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