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Celsius DS D7TCF8L162RTRecalls & reported problems

Biosense Webster Inc · Class 3

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 10846835000399), received between Jun 18, 2018 and Jun 18, 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 Tamponade1
  • No Code Available1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FLUTTER WITH A CELSIUS¿ DS ELECTROPHYSIOLOGY CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING SURGICAL INTERVENTION. DURING ABLATION, A STEAM POP WAS HEARD. ABLATION WAS STOPPED. PATIENT WAS ASSESSED. BLOOD PRESSURE AND HEART RATE REMAINED STABLE AND THE PATIENT DID NOT EXPRESS PAIN. PROCEDURE RESUMED. ANALGESICS (UNSPECIFIED) WERE ADMINISTERED PER ABLATION PROTOCOL. AT THAT POINT, PATIENT BECAME HYPOTENSIVE AND UNRESPONSIVE. TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) REVEALED A CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS INEFFECTIVE, AS BLOOD HAD COAGULATED. PATIENT WAS TRANSFERRED TO THE CARDIOTHORACIC OPERATING ROOM, WHERE AN ATRIAL PERFORATION WAS DETECTED. THERE IS NO INFORMATION REGARDING EXTENDED HOSPITALIZATION OR PATIENT OUTCOME. THERE WERE NO PATIENT FACTORS CITED THAT MAY HAVE CONTRIBUTED TO THE ADVERSE EVENT. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION. THERE WERE NO ISSUES, ERRORS, OR MALFUNCTIONS REPORTED ON ANY BWI PRODUCTS OR EQUIPMENT DURING THE PROCEDURE. NO TRANSSEPTAL PUNCTURE WAS PERFORMED. THERE IS NO SHEATH INFORMATION. GENERATOR WAS SET ON TEMPERATURE CONTROL MODE. THERE IS NO INFORMATION

    Patient problems: Cardiac Tamponade; No Code Available

    MAUDE report 7612409 ↗

Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices

All catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.