PENTARAY NAVRecalls & reported problems across all models

We found 12 models of PENTARAY NAV by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 842 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2017 and Sep 24, 2026 — classified as 9 deaths, 190 injuries, 643 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (293 reports).

4 FDA recall records name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PENTARAY NAV recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 6 of these models · Recall details · FDA record ↗

2. 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 · names 6 of these models · Recall details · FDA record ↗

3. 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 · names 5 of these models · Recall details · FDA record ↗

4. 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 · names 6 of these models · Recall details · FDA record ↗

Most reported PENTARAY NAV problems

PENTARAY NAV models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PENTARAY NAV D128211

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls6 deaths551 reports
• PENTARAY NAV D128208

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls2 deaths237 reports
• PENTARAY NAV D128210

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls31 reports
• PENTARAY NAV D128207

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls15 reports
• PENTARAY NAV D128201

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls6 reports
• PENTARAY NAV D128203

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls1 report
• PENTARAY NAV D128205

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls1 death1 report
• PENTARAY NAV D128202

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128204

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128206

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128209

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  2 recalls0 reports
• PENTARAY NAV D128212

  CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
  1 recall0 reports

Recent PENTARAY NAV adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Patient Device Interaction Problem

  Patient problems: Cardiac Tamponade

  MAUDE report 50891914 ↗
• MalfunctionAug 31, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50525548 ↗
• MalfunctionAug 24, 2026Device Markings/Labelling Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50414632 ↗
• MalfunctionAug 21, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50360641 ↗
• MalfunctionAug 17, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50278591 ↗
• MalfunctionApr 7, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND AFTER USING THE CATHETER INSIDE OF THE PATIENT, THE MEDICAL TEAM NOTICED AN ALERT FROM THE PUMP. THEY THEN DISCOVERED THAT THE DEVICE COULD NO LONGER BE FLUSHED. NO BLOOD CLOTS WERE VISIBLE. MANUAL FLUSHING WAS ALSO EXTREMELY DIFFICULT. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES AT THE START OF ABLATION. A NEW CATHETER HAD TO BE USED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24810843 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) PROCEDURE WITH A PENTARAY NAV CATHETER AND ONE OF THE SPLINES OF THE PENTARAY NAV CATHETER GOT STUCK SHEATH HAS BEEN PHYSICALLY. MANAGED TO COMPLETE THE PROCEDURE WITH THE SAME CATHETER. NO PATIENT CONSEQUENCES. NO DELAY. ADDITIONAL INFORMATION WAS RECEIVED ON 10-MAR-2026 WHICH CLARIFIED THAT AT THE END OF THE PROCEDURE, WHILE PULLING THE PENTARAY NAV CATHETER BACK INTO THE SHEATH, ONE SPLINE BECAME LOOSE. HOWEVER, IT WAS PULLED OUT OF THE PATIENT¿S BODY COMPLETELY TOGETHER WITH THE SHEATH. NO PATIENT INJURIES OR CONSEQUENCES. ADDITIONAL INFORMATION WAS RECEIVED ON 12-MAR-2026. THE DAMAGE DID RESULT IN A WIRE EXPOSED. THE CUSTOMER STATED THERE WAS RESISTANCE WHEN TRYING TO PULL THE CATHETER OUT OF THE SHEATH AT THE "HEIGTH" OF GROIN. DETACHMENT WAS TOTAL. DETACHED SECTION WAS STUCK IN SHEATH. AFTER LOOKING AT THE FLUOROSCOPY, NO FURTHER PARTS WERE VISIBLE INSIDE THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 15-MAR-2026. OCCURRED DURING CATHETER EXCHANGE WITHIN THE TWO SL0 SHEATHS (ABBOTT). WHEN ADVANCING THE CATHETER OUT OF THE SHEATH, AS USUAL UP TO CATHETER DEPLOYMENT, NO ABNORMALITIES. SUBSEQUENTLY, RESTRICTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24778657 ↗
• MalfunctionApr 2, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV WHICH WAS NOT IRRIGATING AND USED ON PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, DEVICE WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. 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 12-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT WHEN DRAINING THE SYRINGE AND INFUSION PUMP, THE OUTLET HOLE OF THE CATHETER SHOULD NOT ALLOW WATER TO FLOW OUT. THERE WAS NO ERROR FROM THE PUMP AND THE CORRECT CATHETER SETTINGS WERE SET ON THE GENERATOR. THE DEVICE WAS USED ON THE PATIENT. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF IRRIGATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED INDICATING THE DEVICE WITH AN IRRIGATION ISSUE WAS USED ON THE PATIENT, THE EVENT WAS ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24764585 ↗
• InjuryMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION WITH A PENTARAY NAV CATHETER AND THE PATIENT EXPERIENCED PERICARDIAL EFFUSION THAT REQUIRED PERICARDIOCENTESIS. A SMALL PERICARDIAL EFFUSION WAS NOTICED AT BASELINE USING ICE (INTRACARDIAC ECHOCARDIOGRAPHY). WHEN LOOKING AT ICE PRIOR TO ABLATION, IT WAS NOTICED THAT THE PERICARDIAL EFFUSION HAD GROWN. IT WAS UNKNOWN IF THE PATIENT HAD ANY VISIBLE SYMPTOMS. THE PATIENT WAS STILL STABLE SO ABLATION WAS PERFORMED AND COMPLETED. THE MEDICAL INTERVENTION PROVIDED TO THE PATIENT WAS A PERICARDIOCENTESIS THAT WAS PERFORMED FOLLOWING ABLATION. THE LAST KNOWN PATIENT STATUS WAS STABLE.

  Patient problems: Cardiac Tamponade

  MAUDE report 24717005 ↗
• MalfunctionMar 30, 2026Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THE TRANSITION IN THE TIP BETWEEN THE ELECTRODES WAS SEPARATED. DEFLECTION ISSUE. DURING THE PROCEDURE, DEVICE WAS UNABLE TO DEFLECT OR RELAX COMPLETELY. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 05-MAR-2026, OBSERVED THE TRANSITION IN THE TIP BETWEEN THE ELECTRODES WAS SEPARATED. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE TRANSITION IN THE TIP BETWEEN THE ELECTRODES WAS SEPARATED ON 05-MAR-2026 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716677 ↗
• MalfunctionMar 25, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND OBSERVED AN IRRIGATION ISSUE (DEVICE USED ON PATIENT). DURING FIRST MAPPING, THE PENTARAY NAV CATHETER WAS OKAY AND COULD BE FLUSHED. HOWEVER, DURING REMAPPING, SUDDENLY THERE WAS NO WATER COMING OUT FROM THE IRRIGATION PATHWAY OF THE CATHETER DURING FLUSHING. THE SOLUTION WAS CHANGING WITH THE NEW CATHETER AND THERE WAS WATER COMING OUT DURING FLUSHING. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. PRESSURE BAG PUMPED TO 300 MM/HG WAS USED. THERE WAS NO ERROR MESSAGE. VISUALLY INSPECTED AND NO WATER DRIPPING OUT OF THE PENTARAY NAV CATHETER BEFORE INSERTING TO PATIENT BODY. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS TRIED TO INCREASE THE PRESSURE BAG PRESSURE TO 400 MM/HG. DISCONNECTED THE TUBING AND FLUSHED. VERIFIED SALINE FLOW BUT NO SALINE WAS DRIPPING OUT OF PENTARAY NAV CATHETER AFTER CONNECTED TO THE PENTARAY NAV CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691492 ↗
• 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 ↗
• MalfunctionMar 20, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV WHICH WAS NOT IRRIGATING AND USED ON PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, DEVICE WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. 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 4-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SUSPECTED ISSUE WAS WITH THE CATHETER. THERE WAS NO ERROR MESSAGE FROM THE IRRIGATION PUP AS A PRESSURIZED BAG WAS USED. THE PENTARAY NAV WAS USED ON THE PATIENT AND THERE WERE NO FLOW RATE ISSUES AT THE START OF IRRIGATION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. BASED ON THE ADDITIONAL INFORMATION RECEIVED INDICATING THE DEVICE WITH AN IRRIGATION ISSUE WAS USED ON THE PATIENT, THE EVENT WAS ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646840 ↗
• MalfunctionMar 17, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV WHICH HAD AN IRRIGATION ISSUE AND USED ON THE PATIENT. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, 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. ON 1-MAR-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO ERRORS GIVEN FROM THE IRRIGATION PUMP; THE PRESSURE BAG IS FULL OF PRESSURE, BUT THERE IS NO WATER FLOWING FROM THE END OF THE MAPPING CATHETER. TO RESOLVE THE ISSUE THEY TRIED TO USE A SYRINGE TO DRIVE INFUSION, USE A WATER PUMP TO FLUSH INFUSION THE CATHETER WAS USED ON THE PATIENT. BASED ON THE NEW INFORMATION THAT INDICATES THE PENTARAY NAV WHICH HAD AN IRRIGATION ISSUE AND USED ON THE PATIENT, THE EVENT WAS ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620841 ↗
• MalfunctionMar 16, 2026Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV AND DURING THE OPERATION, THE SPLINES OF THE CATHETER WAS FOUND BENT (NO EXPOSED WIRES). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. THE DEVICE WAS NOT USED IN PATIENT. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. A PHOTO WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) PROCEDURES. ACCORDING TO THE PHOTO PROVIDED BY THE CUSTOMER, A SPINE WAS OBSERVED SEVERELY BENT AND SQUASHED AND AN ELECTRODE IS OBSERVED SLIGHTLY LIFTED. THIS FINDING IS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24611699 ↗

Other Biosense Webster Inc products

• THERMOCOOL SMARTTOUCH SF8 models · 6,238 reports · 1 recall
• VIZIGO3 models · 5,206 reports · 4 recalls
• QDOT MICRO7 models · 1,418 reports
• ThermoCool SmartTouch7 models · 1,163 reports
• OCTARAY Mapping Catheter6 models · 407 reports
• CARTO VIZIGO2 models · 349 reports
• SOUNDSTAR6 models · 260 reports
• PREFACE3 models · 193 reports