PENTARAY NAV D128201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10846835009576), received between Sep 20, 2021 and Feb 28, 2024 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).

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. How this data works · Data updated Oct 13, 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 · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION WITH A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. A PERICARDIAL EFFUSION WAS NOTICED DURING THE PROCEDURE. THE PATIENT HAD A BASELINE EFFUSION; HOWEVER, ONCE THEY HAD GAINED ACCESS TO THE LEFT SIDE, THE PATIENT'S BLOOD PRESSURE DROPPED AND IT WAS CONFIRMED WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) THAT THE PERICARDIAL EFFUSION HAD GROWN. PERICARDIOCENTESIS WAS PERFORMED. THE PROCEDURE WAS ABORTED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. NO ABLATION HAD BEEN PERFORMED. THEY HAD LOST VIEW OF THE TRANSSEPTAL WIRE ON ICE WHILE PUNCTURING IT AND THAT WAS BELIEVED TO BE THE CAUSE OF THE INJURY. A PENTARAY CATHETER AND AN SMARTTOUCH SF CATHETER WERE INSIDE THE PATIENT'S BODY. ADDITIONAL INFORMATION WAS RECEIVED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER, INC. PRODUCTS. THE SHEATH USED FOR TRANSSEPTAL PUNCTURE WAS THE BAYLIS VERSACROSS WIRE AND SHEATH. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED AS LOST SIGHT OF THE TRANSSEPTAL NEEDLE. PATIENT STAYED AN EXT

  Patient problems: Cardiac Tamponade

  MAUDE report 18804823 ↗
• InjuryDec 14, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  INITIALLY THIS EVENT WAS REPORTED UNDER THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER (MFR # 2029046-2023-02701). HOWEVER, ADDITIONAL INFORMATION WAS RECEIVED ON 16-NOV-2023 STATING THAT THE PENTARAY NAV HIGH-DENSITY MAPPING CATHETER WAS USED FOR MAPPING. THEREFORE, IT WAS ASSESSED TO ALSO REPORT THIS EVENT UNDER THE PENTARAY NAV HIGH-DENSITY MAPPING CATHETER. IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA - RIGHT (R-IDVT) ABLATION PROCEDURE USING THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND THE PENTARAY NAV HIGH-DENSITY MAPPING CATHETER AND EXPERIENCED A PERICARDIAL EFFUSION WHICH REQUIRED A PERICARDIOCENTESIS AND SURGICAL REPAIR. WHILE MAPPING, THE PATIENT EXPERIENCED INCREASED HEART RATE / DECREASED BLOOD PRESSURE AND PERICARDIAL EFFUSION WAS DISCOVERED VIA THE INTRACARDIAC ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND A LARGE AMOUNT OF BLOOD WAS REMOVED FROM THE PERICARDIAL SPACE. THEY WERE NOT ABLE TO CONTROL THE EFFUSION AND THE PATIENT WAS TRANSFERRED TO CT SURGERY FOR SURGICAL REPAIR. ADDITIONAL INFORMATION RECEIVED ON 16-NOV-2023. PENTARAY NAV HIGH-DENSITY MAPPING CATHETER WAS USED TO MAP RIGHT

  Patient problems: Cardiac Tamponade

  MAUDE report 18326065 ↗
• InjuryNov 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE USING A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER. DURING ABLATION, THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED PERICARDIOCENTESIS AND SURGICAL INTERVENTION. THEY WERE ABLATING ON THE POSTERIOR WALL WITH A RMT CATHETER WHEN THE BLOOD PRESSURE DROPPED. A PERICARDIOCENTESIS WAS PERFORMED AND 400 ML WAS REMOVED. HEPARIN WAS REVERSED. THEY RECEIVED 2-3 "HIGH TEMPERATURE" WARNINGS ON THE SMARTABLATE GENERATOR AND THE POWER WAS REDUCED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PENTARAY PERFORATION. PATIENT REQUIRED EMERGENCY SURGERY TO REPAIR. THIS ADVERSE EVENT IS BEING CAPTURED UNDER THE PENTARAY CATHETER TO ALIGN WITH THE PHYSICIAN¿S BELIEF THAT IT WAS THE MOST LIKELY THE CAUSE OF THE PERFORATION.

  Patient problems: Cardiac Perforation

  MAUDE report 18097625 ↗
• InjuryJun 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN UNKNOWN PENTARAY NAV HIGH-DENSITY MAPPING CATHETER. THE PATIENT EXPERIENCED A PLEURAL EFFUSION. DURING THE PROCEDURE, THE PHYSICIAN NOTICED THAT THERE WAS LOW BLOOD PRESSURE WITH A NARROW PULSE PRESSURE DEVELOPING ON THE PATIENT. THE PHYSICIAN WAS USING INTRACARDIAC ECHOCARDIOGRAPHY (ICE) TO SEE IF THERE WAS A PERICARDIAL EFFUSION AND THEY DID NOT OBSERVE ANY SIGNIFICANT CHANGES. UPON USING FLUOROSCOPY, THEY OBSERVED THAT THE RIGHT LUNG HAD DROPPED AND THERE WAS BLOOD IN THE LUNG FIELD. THEY STATED THE PHYSICIAN CONFIRMED THE INJURY WAS A HEMOPNEUMOTHORAX INJURY. THE PATIENT HAD A CHEST TUBE INSERTED AND 4 LITERS OF BLOOD WAS REMOVED FROM THE PATIENT. AT THIS POINT, THE PATIENT HAD STABILIZED AND WAS SENT TO THE SURGICAL UNIT. THE PHYSICIAN WAS UNSURE OF HOW THE INJURY MAY HAVE HAPPENED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Pleural Effusion

  MAUDE report 17045499 ↗
• MalfunctionOct 20, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING AN ANIMAL STUDY SPONSORED BY BIOSENSE WEBSTER INC., (BWI) R&D, WHILE USING A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, IT WAS REPORTED THAT A FOREIGN MATERIAL ¿ ON USABLE LENGTH OF THE CATHETER ISSUE OCCURRED. IT WAS REPORTED THAT WHEN THE PENTARAY CATHETER WAS REMOVED FROM SHEATH, IT WAS NOTICED THAT THE CATHETER HAD A LOT OF "YELLOWISH, WHITE FIBROUS PLASTIC MATERIAL" TANGLED ON THE SPLINES OF THE CATHETER. IT WAS NOTED THAT THE MATERIAL DID NOT APPEAR TO BE BIOLOGICAL. THERE WAS NO RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH. IT WAS REPORTED THAT THE ANIMAL STUDY HAD BEEN COMPLETED AT THIS POINT, AND NO REPLACEMENT CATHETER WAS NEEDED. NO HUMAN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669537 ↗
• MalfunctionSep 20, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DURING AN ANIMAL STUDY SPONSORED BY BIOSENSE WEBSTER INC., (BWI) R&D, WHILE USING A PENTARAY NAV HIGH-DENSITY MAPPING CATHETER, IT WAS REPORTED THAT A FOREIGN MATERIAL ¿ ON USABLE LENGTH OF THE CATHETER ISSUE OCCURRED. IT WAS REPORTED THAT WHEN THE PENTARAY CATHETER WAS REMOVED FROM SHEATH, IT WAS NOTICED THAT THE CATHETER HAD A LOT OF "YELLOWISH, WHITE FIBROUS PLASTIC MATERIAL" TANGLED ON THE SPLINES OF THE CATHETER. IT WAS NOTED THAT THE MATERIAL DID NOT APPEAR TO BE BIOLOGICAL. IT WAS REPORTED THAT THE ANIMAL STUDY HAD BEEN COMPLETED AT THIS POINT, AND NO REPLACEMENT CATHETER WAS NEEDED. NO HUMAN PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12501908 ↗

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