PENTARAY NAV D128208Recalls & reported problems

Summary

The FDA's MAUDE database contains 237 adverse event reports that list this exact device (DI 10846835012224), received between Oct 5, 2017 and Aug 24, 2026 — classified as 2 deaths, 56 injuries, 179 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (81 reports).

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K123837); 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-2372-2020 · 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-0212-2018 · Root cause: Other · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 237 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50414632 ↗
• MalfunctionMar 20, 2026Obstruction of Flow

  THE BIOSENSE WEBSTER INC¿S (BWI) FAILURE ANALYSIS LAB (FAL) RECEIVED A USED PENTARAY NAV CATHETER WHICH WAS VERIFIED TO NOT BE RELATED TO ANY PREVIOUSLY REPORTED COMPLAINT. AS SUCH, BWI OPENED THIS NEW COMPLAINT TO DOCUMENT THE RETURNED DEVICE EVALUATION AND INVESTIGATION DETAILS. FOLLOW-UP WAS DONE TO CLARIFY THE CIRCUMSTANCES RELATED TO THE RECEIVED DEVICE. ON (B)(6) 2026 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CATHETER FLUSHING WAS BLOCKED. THE ISSUE WAS RESOLVED BY CHANGING THE CATHETER AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. AS SUCH, THE CUSTOMER'S REPORTED OCCLUSION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON (B)(6) 2026 ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS USED ON THE PATIENT. IRRIGATION FLOW HAD STOPPED AND THE PUMP GAVE A WARNING. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR AND THERE WERE ON ISSUES RELATED TO FLOW RATE CHANGE AT THE START OF ABLATION. BASED ON THE NEW INFORMATION WHICH INDICATES THE DEVICE WAS USED ON THE PATIENT, THE EVENT WAS REASSESSE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646886 ↗
• MalfunctionFeb 27, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND THE PENTARAY CATHETER TIP BROKE. THER WAS NO WIRES BEING EXPOSED, NOR LIFTED OR SHARP RINGS. THERE WAS NO DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE ISSUE WAS APPROXIMATELY 5CM FROM THE DISTAL END OF THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED. VISUAL ANALYSIS REVEALED A SEPARATION ON THE TIP-SHAFT TRANSITION. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471754 ↗
• MalfunctionFeb 24, 2026Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE TIP SECTION SEPARATED FROM THE SHAFT ON THE DEVICE. CATHETER CURVATURE ERROR. NO PATIENT CONSEQUENCE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2026 THE TIP SECTION SEPARATED FROM THE SHAFT ON THE DEVICE. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE TIP SECTION SEPARATED FROM THE SHAFT ON THE DEVICE ON THE DEVICE ON 31-JAN-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430814 ↗
• MalfunctionFeb 17, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND IT WAS NOT POSSIBLE TO FLUSH THE CATHETER DURING THE PROCEDURE. DURING USE OF THE PENTARAY NAV, IT WAS NOT POSSIBLE TO FLUSH THE CATHETER ON HIGH OR LOW FLOW WITH THE PUMP OR MANUALLY. THEY HAD A HIGH PRESSURE ERROR VIA INFUSOMAT PUMP (B.BRAUN). THE CORRECT CATHETER SETTINGS HAD BEEN SELECTED ON THE GENERATOR. THE CATHETER WAS EXCHANGED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24373664 ↗
• MalfunctionFeb 17, 2026Material Separation; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND THE MEDICAL TEAM REPORTED THAT THE "CATHETER BODY WAS STRIPPED AT THE JUNCTION OF THE TWO COLORS OF THE CATHETER BODY. SO CURVATURE NO LONGER RESPONDS". THERE WAS SMALL RESISTANCE NOTED DURING INSERTION. THE CATHETER WAS NOT PRE-SHAPED. HOWEVER, A PARTIAL SEPARATION OF THE CATHETER TIP WAS NOTED. PHOTOGRAPHS HAVE BEEN PROVIDED BY THE CUSTOMER AS WELL. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367679 ↗
• MalfunctionJan 30, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV. INITIALLY, IT WAS INDICATED THAT EVEN IF HEPARINIZED SALINE SOLUTION WAS USED, THE CATHETER WAS CLOGGED AND SO THEY CHANGED THE CATHETER TO PERFORM THE CASE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 07-JAN-2026, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE SUSPECTED DEVICE IS THE CATHETER. IT ALSO INDICATED THAT THE PHYSICIAN USED THE CATHETER FOR FIRST MAP. THERE WAS NO PROBLEM. THEN, THEY COMPLETED THE ABLATION PROCESS. THE PHYSICIAN WANTED TO CREATE REMAP TO CHECK BUT BEFORE USING IT, HE REALIZED THERE WERE NO DROPS FALLING FROM CATHETER TIP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THEREFORE, THE EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 07-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226164 ↗
• MalfunctionJan 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER, AND AFTER THE DEVICE HAD BEEN REMOVED FROM THE PATIENT AFTER ABLATION AND DISCONNECTED FROM IRRIGATION, WHEN IT WAS PUT BACK INSIDE THE PATIENT IT SEEMED LIKE THE IRRIGATION WAS 'STUCK'. NO IRRIGATION WAS COMING OUT OF THE PENTARAY CATHETER FOR SUBSEQUENT ATTEMPTS TO USE THE DEVICE. FLUSH COULD NOT BE PERFORMED. THE CATHETER WAS CHANGED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24192219 ↗
• MalfunctionJan 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV. INITIALLY, IT WAS INDICATED THAT DURING OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 28-DEC-2025, ADDITIONAL INFORMATION WAS RECEIVED WHICH CONFIRMED THAT THE SUSPECTED DEVICE IS THE CATHETER AND THAT IT WAS USED IN THE PATIENT. THEREFORE, THE EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 28-DEC-2025. IT WAS ALSO INDICATED THAT THE ¿HEAD END DOES NOT PRODUCE WATER¿. A PRESSURE BELT WAS USED (NO PUMP WAS USED). THE STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WERE PRESSURIZATION AND FLUSHING. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WAS NO ISSUE WITH FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24168660 ↗
• MalfunctionJan 14, 2026Complete Blockage; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV. AT THE BEGINNING OF THE CASE, THERE WAS NO PROBLEM WITH THE CATHETER¿ S IRRIGATION POLE. THEY NOTICED THAT FLUID WITH HEPARIN FLOW STOPPED AT THE MIDDLE OF THE CASE. FLUSHING DID NOT SOLVE THE PROBLEM. WHEN THE CATHETER WAS REPLACED WITH A NEW ONE, THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065079 ↗
• MalfunctionJan 9, 2026Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTANT ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE, WITH A PENTARAY NAV, AND FIBERS WERE NOTICED AROUND THE SPLINE. DURING MAPPING WITH PENTARAY CATHETER, THE MANEUVERABILITY SUDDENLY CHANGED ("GOT WORSE") AND THE PATIENT HAD SOME EXTRA BEATS, WHICH HE DID NOT HAVE PRIOR TO THAT. THE CATHETER WAS PULLED IMMEDIATELY, AND FIBERS WERE NOTICED AROUND THE SPLINES (ORIGIN UNCLEAR). THE SURGERY WAS NOT DELAYED. THE CATHETER WAS ¿DISMISSED AND CHANGED¿. THE CATHETER WAS EXCHANGED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO TALK ABOUT RESISTANCE, BUT THE CATHETER WAS ALREADY INSIDE THE CHAMBER AND ACTIVELY MAPPING. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24023781 ↗
• MalfunctionJan 9, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE OCCURRED. DURING THE ABLATION PROCEDURE, THEY NOTICED THE IRRIGATION WAS NOT FLOWING OUT OF THE PENTARAY. THE PHYSICIAN TRIED TO FLUSH WITH A SYRINGE, BUT NO IRRIGATION CAME OUT OF THE CATHETER. THEY CHANGED TO A NEW CATHETER. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER. NO ERROR MESSAGE ON CARTO SYSTEM. THERE WAS NO SIGNAL NOISE ON CARTO AND EP RECORDING SYSTEM. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017553 ↗
• MalfunctionJan 8, 2026Failure to Sense

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND A MAGNETIC ERROR WAS OBSERVED. THE CABLE WAS REPLACED, AND THE PIU WAS RESTARTED, AND CHECKED THE ¿MAGNETIC OF PATCH¿; HOWEVER, THE PROBLEM WAS NOT RESOLVED. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND MEASUREMENT OF THE SENSOR PINS RESISTANCE WAS PERFORMED. VISUAL INSPECTION REVEALED A SEPARATION OF THE TIP WITH THE SHAFT WITH EXPOSED WIRES. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000890 ↗
• MalfunctionDec 19, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV WHICH DID NOT IRRIGATE WELL DURING USE ON THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE CATHETER DID NOT IRRIGATE WELL, THE IRRIGATION DID NOT PASS THROUGH THE CATHETER. WE CHANGED IT, AND THE PROBLEM WAS SOLVED. THE CUSTOMER'S REPORTED OCCLUSION ISSUE IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON(B)(6) 2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT DURING THE FIRST MOMENTS OF USE, THE CATHETER PERFUSED NORMALLY WITH NO ERROR MESSAGES. AFTER APPROXIMATELY ONE MINUTE OF PERFUSION, THE EXTERNAL PUMP DISPLAYED AN OBSTRUCTION/FLOW-BLOCK MESSAGE, INDICATING THAT PERFUSION WAS NOT PASSING THROUGH THE CATHETER. FOR TROUBLESHOOTING THE PERFUSION FLOW RATE WAS DECREASED TO THE MINIMUM SETTING, BUT THE OBSTRUCTION MESSAGE PERSISTED. THE CATHETER WAS VISUALLY INSPECTED TO ASSESS POTENTIAL OBSTRUCTION. ALTHOUGH NO VISIBLE BLOCKAGE WAS IDENTIFIED, THE PERFUSION SOLUTION DID NOT APPEAR TO EXIT THROUGH THE CATHETER. THE CATHETER WAS REPLACE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854651 ↗
• MalfunctionNov 26, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND THE CATHETER SPLINES GOT STUCK IN THE MECHANICAL MITRAL VALVE. SPLINES ARE NOT WORKING AND THEY CHANGED THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND DIMENSIONAL TEST WERE PERFORMED. VISUAL ANALYSIS REVEALED THAT ONE OF THE SPLINES WAS DETACHED, WITH EXPOSED WIRES, MISSING ELECTRODES AND STRESS MARKS. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23653647 ↗
• MalfunctionOct 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH PENTARAY NAV CATHETER AND AN IRRIGATION ISSUE OCCURRED (DEVICE USED ON PATIENT). INITIALLY REPORTED THAT THEY COULD NOT "FLUSH" THE PENTARAY NAV CATHETER PRIOR TO ADVANCING IT INTO THE BODY. IT WOULD NOT FLUSH REGARDLESS OF THE HIGH FORCE USED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. A SMARTABLATE® GENERATOR WAS IN USE. ADDITIONAL INFORMATION WAS RECEIVED ON 23-SEP-2025. THE SUSPECTED DEVICE FOR THE REPORTED FLOW / IRRIGATION ISSUE WAS THE CATHETER. THE DEVICE WAS USED ON THE PATIENT. IT INITIALLY FLUSHED AND WAS USED. IT WAS EXCHANGED FOR AN ABLATION CATHETER AND BEFORE REINSERTING THE PENTARAY, IT COULD NOT BE FLUSHED. TRIED TO FLUSH WITH PRESSURE BAG AND MANUALLY WITH SYRINGE. NO SUCCESS. THIS IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 23-SEP-2025 THAT THE DEVICE WAS USED ON THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 23-SEP-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23326548 ↗
• MalfunctionOct 17, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND AN IRRIGATION ISSUE OCCURRED MID PROCEDURE. THE CASE WAS STARTED AND THE PENTARAY HAD BEEN FLUSHED. NO ISSUES WERE DETECTED AT THIS POINT. HOWEVER, AS THE CASE PROGRESSED, THE FLUID FLOW WAS BLOCKED. THERE WAS NO ERROR MESSAGE. THE PUMP WAS USED WITH PENTARAY AND WAS REGULARLY ADJUSTED TO 2 ML/MIN BUT WAS CLOGGED AFTER A WHILE. THE PHYSICIAN REMOVED THE PENTARAY FROM THE PATIENT'S BODY AND CONFIRMED THAT THERE WAS NO FLUID FLOW. THE CABLE AND LINE WERE CHANGED BUT THE PROBLEM COULD NOT BE SOLVED. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23320921 ↗
• MalfunctionSep 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IT WAS NOTICED THAT THE PENTARAY NAV WAS NOT FLUSHING AT ALL BEFORE READVANCING THE PENTARAY NAV BACK INTO THE BODY FOR A POST-MAP. THE PENTARAY NAV WAS FLUSHED BUT THE ISSUE PERSISTED. THE PENTARAY NAV WAS REPLACED AND THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. THE CALLER STATED THAT THE FAULTY PENTARAY NAV WAS BRAND NEW. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23042864 ↗
• MalfunctionSep 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND WAS UNABLE TO FLUSH THE CATHETER. IT WAS REPORTED THAT A PENTARAY® BECAME "CLUDED" BETWEEN THE INITIAL MAP AND THE FINAL MAP. THEY HOOKED UP A SYRINGE AND TRIED TO FLUSH THROUGH THE PENTARAY® WITH THE SYRINGE BUT COULD NOT. A PRESSURE BAG WAS USED. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED AND THE CASE CONTINUED. A REPLACEMENT CATHETER WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22967400 ↗
• MalfunctionSep 4, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV WHICH HAD A FLUID FLOW BLOCK. WHEN THE CASE STARTED, THE PENTARAY NAV WAS FLUSHED., BUT DURING THE CASE IT WAS DETECTED THAT THE FLUID FLOW WAS BLOCKED. THE CABLE AND LINE WERE CHANGED BUT THE PROBLEM COULD NOT BE SOLVED. A NEW CATHETER WAS OPENED AND THE PROBLEM WAS SOLVED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960310 ↗
• MalfunctionAug 27, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS INITIALLY REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV IT WAS NOT POSSIBLE TO FLUSH IT WITH THE BRAUN INFUSOMAT SPACE PUMP OR MANUALLY. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER'S REPORTED OCCLUSION IS NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT IS REMOTE. ON 25-AUG-2025, ADDITIONAL INFORMATION WAS RECEIVE INDICATING HE ISSUE WAS NOTICED DURING THE PROCEDURE AS THERE WAS A ¿PUMP ALARM¿ BECAUSE OF HIGH PRESSURE WHILE THEY WERE MAPPING. AFTER REMOVING THE PENTARAY NAV OUT OF THE PATIENT THEY NOTICED THERE WAS NO FLOW AT THE TIP OF THE CATHETER; FLUSHING THE CATHETER MANUALLY WAS ALSO NOT POSSIBLE. BASED ON THE ADDITIONAL INFORMATION RECEIVED WHICH INDICATED THE IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22906277 ↗
• MalfunctionAug 26, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND IT WAS NOT FLUSHING DURING USE ON THE PATIENT. PRIOR TO REINSERTING THE PENTARAY NAV CATHETER FOR POST-PFA MAPPING, IT WAS DISCOVERED TO NOT BE FLUSHING . THE CATHETER WAS EXCHANGED WITH A NEW PENTARAY NAV CATHETER TO CONTINUE. THERE WERE NO ERRORS FROM THE BD ALARIS PUMP AS THE CATHETER WAS HAND FLUSHED AND IT WOULD NOT FLUSH. THE CORRECT CATHETER SETTINGS WERE SET ON THE GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901374 ↗
• MalfunctionAug 26, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV IT WAS NOT POSSIBLE TO FLUSH IT. THERE WAS A ¿PRESSURE ALARM¿ VIA THE BRAUN INFUSOMAT; NO ERROR FROM THE NGEN PUMP, BUT NO LIQUID LEAKED OUT OF THE DISTAL END OF THE PENTARAY NAV. AFTER REMOVING THE PENTARAY NAV OUT OF THE PATIENT IT WAS NOT POSSIBLE TO FLUSH IT MANUALLY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22898400 ↗
• MalfunctionAug 22, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV CATHETER AND WHEN IT WENT BACK INTO THE BODY, IT COULD NOT FLUSH. THE PHYSICIAN TRIED A HARD FLUSH WITH A 20CC SYRINGE, BUT THE ISSUE REMAINED. THE CATHETER WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22879921 ↗
• MalfunctionAug 15, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND THE PROCEDURE AND PREPARATION STARTED AS USUAL. AFTER SOME TIME, PHYSICIAN NOTICED THE IRRIGATION OF THE PENTARAY CATHETER WAS VERY SLOW. THE VALVE WAS FULLY OPENED. THE PRESSURE OF THE BAG INCREASED UP TO 400MMHQ AND THERE WAS NO CHANGE. PENTARAY WAS TAKEN OUT AND MANUAL FLUSHING WITH A SYRINGE WAS NOT POSSIBLE. THE CASE WAS CONTINUED AND FINISHED WITH SLOW IRRIGATION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123837. One submission often covers many models, so check the product and lot details in each record.

• Z-0211-2018 · May 17, 2017 · Terminated
  PENTARAY NAV High-Density Mapping Catheter.
• Z-1591-2016 · Apr 14, 2016 · Terminated
  Pentaray NAV High-Density Mapping ECO Catheter, Catalog No. D128207, D128208, D128209, D128210, D128211, D128212 The Biosense Webster Pentaray NAV High-Density Mapping Catheter is
• 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