ISMUS D7R20P14CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835005936), received between Aug 26, 2022 and Aug 26, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

4 other recalls cover devices cleared under the same FDA submission (K953768); they may or may not involve this specific model.

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

Recent adverse event reports

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

• InjuryAug 26, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN PERSISTENT ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND AN ISMUS®CATH ELECTROPHYSIOLOGY CATHETER WITH AUTO ID. THE PATIENT SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IT WAS REPORTED THAT A COUPLE OF HOURS AFTER THE PROCEDURE WAS COMPLETED, A PERICARDIAL EFFUSION WAS NOTICED. THE PATIENT EXPERIENCED CHEST PAIN AND HIGH BLOOD PRESSURE. THE PERICARDIAL EFFUSION WAS CONFIRMED WITH TTE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS AND 500 CC¿S OF FLUID WERE REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PHYSICIAN WAS UNSURE OF HOW THE ISSUE OCCURRED BUT THAT HE BELIEVED IT COULD HAVE BEEN CAUSED BY THE 7FR ATRIAL DEFL CATH-CARTO 3. THE PATIENT WAS BEING SENT HOME ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED. THIS ADVERSE EVENT WAS DISCOVERED POST USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT MAYBE IT WAS THE DUADECA CATHETER. THE PATIENT OUTCOME OF THE ADVERSE EVENT IS FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF THE ADVERSE EVENT

  Patient problems: Cardiac Tamponade

  MAUDE report 15306412 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K953768. One submission often covers many models, so check the product and lot details in each record.

• Z-2665-2011 · May 23, 2011 · Terminated
  HALO Catheter with Auto 10 Technology, Part Number D-1160-43-S, Catalog Number D7T20282CT The affected catheters are indicated for multiple electrode electrophysiological mapping
• Z-2664-2011 · May 23, 2011 · Terminated
  ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # D7R20P14CT The affected catheters are indicated for multiple electrode electrophysiological
• Z-3037-2011 · Apr 29, 2011 · Terminated
  ISMUS Catheter Mapping Catheter with Auto ID Technology, Manufacturing Part Number D-1171-34-S, Catalog Number D7R20P14CT The ISMUS Catheter with Auto ID Technology has been desig
• Z-3038-2011 · Apr 29, 2011 · Terminated
  Duo-Decapolar Electrophysiology Catheter, Manufacturing Part Number D-1171-35-S, Catalog Number D728260RT Duo-Decapolar Electrophysiology Catheter has been designed for electrophy