ISMUS D7R20P14RTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10846835005950), received between Oct 10, 2024 and Mar 28, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN ISMUS CATHETER AND THE PATIENT EXPERIENCED DEVICE ENTRAPMENT THAT REQUIRED SNARE REMOVAL. IT WAS REPORTED THAT THE ISTHMUS CATHETER GOT CAUGHT ON ITSELF WHILE IT WAS INSIDE OF THE BODY. IT WAS BELIEVED THE CATHETER WAS CAUGHT WITH SOME TISSUE AND WAS WRAPPED AROUND THE SHAFT OF THE CATHETER. THE ONE ELECTRODE ON THE CATHETER COULD NOT BE FREED. A SNARE WAS INSERTED IN THE BODY TO PULL THE CATHETER OUT OF THE MAIN SHEATH. THERE WERE NO VISIBLE TISSUE ON THE CATHETER AFTER IT WAS REMOVED FROM THE BODY. THEY USED THE ULTRASOUND MACHINE EXTENSIVELY TO CONFIRM THERE WAS NO INJURY TO THE HEART, PATIENT OR ANY GROIN ISSUES. IT WAS UNKNOWN IF ANY MEDICAL INTERVENTION WAS PROVIDED FOR THE PATIENT. IT WAS UNKNOWN WHAT LED UP TO THE DISCOVERY OF THE DEVICE PATIENT COMPLICATION. THE ISMUS CATHETER WAS REPLACED WITH A DECANAV CATHETER AND THE PROCEDURE CONTINUED. THEY REQUESTED THE CATHETER TO BE SENT IN FOR EXAMINATION TO SEE IF THERE WAS ANYTHING ON THE ELECTRODE, OR IF THERE WAS ANYTHING PULTRUDING THAT COULD HAVE CAUGHT THE TISSUE THAT COULD HAVE CAUSED THE ISSUE. IN A MORE DETAILED RESPONSE, IT WAS R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21727163 ↗
• InjuryOct 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A ISMUS AND THE PATIENT EXPERIENCED MITRAL VALVE INSUFFICIENCY THAT REQUIRED HOSPITALIZATION. IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, A MITRAL REGURGITATION AND A PARTIAL MI (MITRAL INSUFFICIENCY) IN THE LEFT ATRIUM WAS NOTICED. DURING POST MAPPING, THE PATIENTS VITALS WERE DROPPING DRASTICALLY TO THE POINT WHERE HE ALMOST WENT INTO CARDIAC ARREST. THE PATIENT¿S BLOOD PRESSURE DRASTICALLY DROPPING LED TO THE DISCOVERY. THE PHYSICIAN CONFIRMED THE INJURY WITH CARDIAC ANESTHESIA. THE PATIENT WAS GIVEN EPINEPHRINE WHICH HELPED WITH THEIR BLOOD PRESSURE. THE PATIENT WAS THEN TAKEN TO THE INTENSIVE CARE UNIT (ICU) WHERE HIS VITALS CAME BACK TO RELATIVELY NORMAL. TWO CATHETERS WERE USED DURING THE PROCEDURE. THE CAUSE OF THE INJURY WAS REPORTEDLY DUE TO SCARING ON THE PATIENT¿S LEFT ATRIUM AND THE MITRAL REGURGITATION. IT WAS STATED THAT "HE LOOKED LIKE A SICK PATIENT". THE PATIENT IMPROVED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS PATIENT CONDITION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20424664 ↗

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-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
• 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