PENTARAY NAV D128205Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846835009613), received between Nov 8, 2024 and Nov 8, 2024 — classified as 1 death.

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K120425); 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.

Recalls naming this device

1. Apr 22, 2020Terminated

   Mapping Catheter can become entrapped in the cardiac valvular apparatus while the user is attempting to create an electroanatomic map.

   Z-2371-2020 · Root cause: Error in labeling · Recall details · FDA record ↗

2. May 17, 2017Terminated

   Contraindication language updated in the Instructions For Use (IFU) to indicate that Pentaray Catheters should not be used in patients with prosthetic valves.

   Z-0211-2018 · Root cause: Other · Recall details · FDA record ↗

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.

• DeathNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER AND THE PATIENT EXPERIENCED CARDIAC ARREST / CARDIAC TAMPONADE / PERFORATION THAT REQUIRED CPR, PERICARDIOCENTESIS, BLOOD TRANSFUSION. THE PATIENT DIED. AFTER MAPPING IN THE LEFT ATRIUM WITH THE PENTARAY CATHETER THE TRANSSEPTAL ACCESS WAS LOST. THE PHYSICIAN PERFORMED ANOTHER TRANSSEPTAL PUNCTURE AND PROCEEDED WITH THE CRYO CATHETER TO DELIVERY THERAPY IN THE LEFT ATRIUM. WHILE DELIVERING THERAPY AROUND THE LIPV (LEFT INFERIOR PULMONARY VEIN) AND THE GANGLIONIC PLEXI THE PATIENT "WENT VAGAL." ANESTHESIA NOTIFIED THE PHYSICIAN THAT THE PATIENT AND WAS "LOSING BLOOD PRESSURE" DETECTED FROM THE ARTERIAL LINE. THE PHYSICIAN PLACED A QUAD CATHETER INTO THE RIGHT VENTRICLE "TO GET MORE PRESSURE INTO THE VENTRICLE." CPR WAS ADMINISTERED. A CODE BLUE WAS CALLED, AND BOTH THE CATH LAB AND EP LAB X-RAY TECHS CONTINUED TO DO CPR. OTHER EMERGENCY PERSONNEL CAME TO PROVIDE BLOOD TRANSFUSIONS AND MEDICINE FOR ANESTHESIA. DURING THE EMERGENCY, THE PHYSICIAN NOTICED THE TAMPONADE VIA ICE (INTRACARDIAC ECHOCARDIOGRAPHY) AND BEGAN SUCKING BLOOD OUT OF THE PERICARDIUM. AFTER ABO

  Patient problems: Cardiac Arrest; Cardiac Perforation

  MAUDE report 20636885 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120425. One submission often covers many models, so check the product and lot details in each record.

• Z-0212-2018 · May 17, 2017 · Terminated
  PENTARAY NAV High-Density Mapping Catheter.
• Z-1590-2016 · Apr 14, 2016 · Terminated
  Pentaray NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128203, D128204, D128205, D128206 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is int
• Z-1176-2014 · Feb 20, 2014 · Terminated
  PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster