Celsius D7TBL252RTRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835006056), received between Dec 14, 2023 and Dec 14, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 14, 2023Break; Break
IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA RIGHT (R-AT) PROCEDURE WITH A CELSIUS¿ ELECTROPHYSIOLOGY CATHETER AND A WIRES EXPOSED ISSUE OCCURRED. THE PHYSICIAN UNPACKED THE PRODUCT TO USE IN THE PROCEDURE. THEN HE FOUND THAT THE TIP OF THE CATHETER HAD MORE CURLINESS THAN USUAL. THEREFORE, THE PHYSICIAN HAD A CONCERN ABOUT SAFETY OF THE PATIENT. THEY SENT BACK THE PRODUCT TO THE COMPANY FOR INVESTIGATION. THEY COULD NOT FIND IN THE CATALOG THE DETAIL ABOUT THE CURVE DEGREE OF CATHETER TIP BEFORE NOD ADJUST. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 09-OCT-2023. THIS COMPLAINT WAS FOUND BEFORE THE PROCEDURE AT OPENING. THE PRODUCT HAD NOT BEEN USED. ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2023. THE DAMAGE RESULTED IN WIRES BEING EXPOSED. USER INSPECTED BY EYE BEFORE INSERTION. CURVE WAS WEIRD MORE THAN AS USUAL AND PHYSICIAN CONCERNED IF CATHETER WAS TO BE INSERTED INTO THE HEART. OR WITH THE CURVE LIKE THIS DURING ABLATION, CURVE WILL NOT BE STABLE AND IT MIGHT TOUCH THE ATRIOVENTRICULAR (AV) NODE. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT WIRES WERE EXPOSED ON 16-NOV-2023 AND HAVE REA
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18330067 ↗
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- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
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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 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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