Celsius D6TCAL252RTRecalls & reported problems
Biosense Webster Inc · Class 3
Data updated Oct 13, 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 10846835004625), received between Nov 29, 2018 and Nov 29, 2018 — 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A (B)(6) MALE PATIENT WITH A DIAGNOSIS OF TACHYCARDIA INDUCED CARDIOMYOPATHY AND IN-UTERO SVT UNDERWENT AN ABLATION PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND SUFFERED CARDIAC ARREST REQUIRING CHEST COMPRESSIONS. DURING AND POST ABLATION PHASE, THE HEART RATE INCREASED. REMINDER OF THE PROCEDURE WAS ABORTED. PATIENT¿S BLOOD PRESSURE DROPPED, AND THE PHYSICIAN CHECKED FOR AN EFFUSION. PERICARDIAL EFFUSION WAS NOT OBSERVED. THE PATIENT WENT INTO CARDIAC ARREST AND CHEST COMPRESSIONS WERE APPLIED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. EXTENDED HOSPITALIZATION WAS NOT REQUIRED AS A RESULT OF THE ADVERSE EVENT. PATIENT¿S OUTCOME IS IMPROVED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PATIENT CONDITION-RELATED. PER CELSIUS® DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER IFU, THE USAGE OF THIS DEVICE IS INDICATED FOR CATHETER-BASED ATRIAL AND VENTRICULAR ELECTROPHYSIOLOGIC MAPPING AND FOR USE WITH COMPATIBLE RADIO FREQUENCY GENERATORS IN ADULTS AND CHILDREN 4 YEARS OF AGE OR OLDER IN CREATING ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIA. IT IS CONTRAINDICATED TO USE THE 8-FRENCH B
Patient problems: Cardiac Arrest
MAUDE report 8118093 ↗
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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