PENTARAY NAV D128211Recalls & reported problems

Summary

The FDA's MAUDE database contains 551 adverse event reports that list this exact device (DI 10846835012255), received between Aug 22, 2017 and Sep 24, 2026 — classified as 6 deaths, 119 injuries, 426 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (201 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 551 reports, 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 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

  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 ↗
• MalfunctionMar 16, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND DURING THE PROCEDURE THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE DEVICE HAD ALREADY BEEN USED ON THE PATIENT. SYRINGE EXTRACORPOREAL ASPIRATION WAS ATTEMPTED TO NO AVAIL. THE CORRECT CATHETER SETTINGS WERE SELECTED O THE GENERATOR. THERE WERE NO FLOW RATE CHANGE ISSUES AT THE START OF ABLATION. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24609264 ↗
• MalfunctionMar 6, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV CATHETER AND OBSERVED AN OCCLUSION/NO IRRIGATION ISSUE (DEVICE WAS USED IN THE PATIENT). OCCLUSION/ NO IRRIGATION. DURING THE PROCEDURE, DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2026. THE DEVICE WAS USED IN THE PATIENT. SMARTABLATE PUMP WAS USED. NO ERROR WAS NOTED FROM THE IRRIGATION PUMP. AT FIRST, THE PATIENT WAS ABLE TO PERFORM NORMAL PERFUSION AND THEN, TOOK OUT THE BODY FOR PLACEMENT. WHEN USED AGAIN, IT WAS FOUND THAT THE PERFUSION HOLE WAS BLOCKED. CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF IRRIGATION. THE OCCLUSION/NO IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 10-FEB-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 10-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537959 ↗
• MalfunctionMar 2, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV. INITIALLY, IT WAS INDICATED 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 THE PATIENT. WITH THE INITIAL INFORMATION AVAILABLE, THIS EVENT WAS ASSESSED AS NON MDR REPORTABLE. HOWEVER, ON 04-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE ISSUE WAS NOTED DURING THE TIME THAT THE DEVICE WAS USED ON THE PATIENT. THERE WAS NO IRRIGATION PUMP USED AS A PRESSURE BAG WAS USED. NO WATER WAS FOUND AFTER RINSING WITH A PRESSURE BAG, AND EVEN AFTER RINSING WITH A 200ML SYRINGE, NO WATER WAS FOUND. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THEREFORE, THE EVENT WAS RE-ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 04-FEB-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491974 ↗
• MalfunctionFeb 27, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE OCCURRED DURING USE ON THE PATIENT. IT WAS REPORTED THAT THE MAPPING CATHETER (PENTARAY NAV) WAS REMOVED TO INSERT THE THERMOCOOL SMARTTOUCH SF (STSF) ABLATION CATHETER. AFTER ABLATION, THE STSF WAS SUPPOSED BE EXCHANGED WITH THE PENTARAY NAV FOR POST ABLATION MAPPING, BUT THE IRRIGATION OF PENTARAY NAV WAS NOT WORKING ANYMORE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474945 ↗
• MalfunctionFeb 24, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND IT WAS NOT IRRIGATING. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT DURING THE OPERATION, THE PENTARAY NAV 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 5-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS USED ON THE PATIENT. NO PUMP WAS USED, A SALTWATER PRESSURIZED BAG WAS USED. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. TO RESOLVE THE ISSUE THEY TRIED TO INCREASE THE PRESSURE ON THE PRESSURE BAG, REPLACE THE INFUSION STRIP, AND USE A SYRINGE TO PUSH THE INJECTION. BASED ON THE ADDITIONAL INFORMATION INDICATING THEY USED THE DEVICE WITH AN IRRIGATION ISSUE ON THE PATIENT, THE EVENT WAS REASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436665 ↗
• MalfunctionFeb 23, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND DURING THE OPERATION, THE DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. THE CATHETER WAS PRIMED WITH A PRESSURIZED BAG INSTEAD OF USING AN IRRIGATION PUMP, AND IT WAS FOUND THAT THE HEPARIN WATER IN THE PRESSURIZED BAG COULD NOT DRIP OUT. FLUSHING THE IRRIGATION PORT WITH A SYRINGE WAS "TOO STRESSFUL TO FLUSH". THE DEVICE HAD BEEN USED ON THE PATIENT PRIOR TO NOTING THE ISSUE. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24420882 ↗
• MalfunctionFeb 20, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND OBSERVED AN INTERMITTENT OR LOW IRRIGATION (DEVICE USED IN THE PATIENT) ISSUE. IRRIGATION INADEQUATE. DURING THE PROCEDURE, THERE WAS AN INTERMITTENT OR LOW IRRIGATION ON THE DEVICE BUT NOT COMPLETE OCCLUSION. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 29-JAN-2026. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. THE DEVICE WAS USED IN THE PATIENT. NO ERROR WAS NOTED FROM THE IRRIGATION PUMP. THE ISSUE WAS DISCOVERED WHILE PERFORMING FLUSH. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS REPEATED FLUSHING. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THE INTERMITTENT OR LOW IRRIGATION ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 29-JAN-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 29-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408249 ↗
• MalfunctionFeb 20, 2026Contamination /Decontamination Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A PENTARAY NAV AND A PLASTIC STRING ATTACHED TO ONE OF THE ELECTRODES WAS NOTICED RIGHT OUT OF THE PACKAGE. THE CATHETER WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. A REPLACEMENT CATHETER WAS REQUESTED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT INDICATED THAT THE FOREIGN OBJECT IS CLEAR PLASTIC AND EMBEDDED ON DEVICE WITH NO MOVEMENT. THE DEVICE WAS USED ON THE PATIENT BEFORE THE ITEM WAS NOTICED. MULTIPLE ATTEMPTS WERE MADE TO CLARIFY THE ADDITIONAL INFORMATION RECEIVED AS CONTRADICTORY TO WHAT WAS INITIALLY REPORTED. NO RESPONSE HAS BEEN RECEIVED AT THE TIME OF REPORTING. ABLATION SYSTEM IN USE: NGEN¿ GENERATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24398448 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak; Material Separation; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV CATHETER AND A CRACK ISSUE WAS OBSERVED. THE CATHETER WAS LEAKING AT THE BASE BEFORE THE ELECTRODES ALONG THE SHAFT OF THE CATHETER. FOUND A VISIBLE CRACK WHERE THE LEAK WAS COMING FROM. THEY HAD NOT INSERTED THE CATHETER INTO THE BODY WHEN THIS WAS DISCOVERED. THE ISSUE WAS RESOLVED WHEN THE CATHETER WAS REPLACED. THE CATHETER WAS BRAND NEW AND NOT REPROCESSED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THE CATHETER HAD NOT BEEN INSERTED INTO A SHEATH OR THE BODY WHEN THE LEAK WAS FOUND. THEY WERE TESTING THE FLUSHING BEFORE ADVANCING INTO THE BODY. THE LEAK WAS RIGHT BELOW THE SHAFT ELECTRODES. THE DEVICE WAS NOT PRE-SHAPED. THE CATHETER LEAK ISSUE WAS ASSESSED AS NON MDR REPORTABLE. CATHETER LEAK WAS HIGHLY DETECTABLE BY THE PHYSICIAN. THE MOST LIKELY CONSEQUENCE WAS AN INTRAPROCEDURAL DELAY. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE CRACK ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397108 ↗
• MalfunctionFeb 19, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND WHEN THE PENTARAY NAV CATHETER WAS REMOVED FROM THE BODY DURING TROUBLESHOOTING, AND AFTER ADVANCING IT BACK INTO THE BODY, IT WAS NOT FLUSHING CORRECTLY. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE REPORTER NOTED THAT IT WAS A BRAND-NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT INITIALLY, WHILE USING THE PENTARAY, THERE WERE NO ISSUES. THEN, THE PHYSICIAN REMOVED THE PENTARAY AFTER FIRST MAP. WHEN THE PHYSICIAN WANTED TO RE-MAP AGAIN, WITH THE SAME PENTARAY, IT WAS NOTED THAT THERE WAS NO FLOW THROUGH PENTARAY. A NGEN PUMP WAS USED AND THERE WERE NO ERRORS NOTED. THE PHYSICIAN NOTICED NO FLOW THROUGH PENTARAY, ALTHOUGH THEY WERE TRYING TO FLUSH. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THEY TRIED TO RESOLVE THE ISSUE, AND THE TUBING WAS CHECKED AND RESEATED. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24393959 ↗
• MalfunctionFeb 19, 2026Obstruction of Flow

  A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER THAT WAS NOT FLUSHING AFTER TRYING TO REINSERT IT BACK INTO THE PATIENT. IT WAS DISCOVERED THAT THE LUMEN WAS NOT FLUSHING WHEN THE PENTARAY NAV CATHETER WAS INSERTED BACK INTO THE PATIENT FOR REMAPPING. THEY EXCHANGED THE CATHETER TO RESOLVE AND CONTINUE THE CASE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING IT IS THE PENTARAY NAV CATHETER THAT WAS SUSPECTED TO HAVE THE IRRIGATION ISSUE SINCE NO PUMP WAS USED DURING THIS CASE. THE CATHETER WAS ON A CONTINUOUS PRESSURE BAG INFUSION OF HEPARINIZED SALINE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389901 ↗
• MalfunctionFeb 18, 2026Obstruction of Flow; Computer Operating System Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND IT WAS NOT POSSIBLE TO FLUSH THE CATHETER ANYMORE WITH PUMP OR MANUALLY DURING PROCEDURE, A HIGH-PRESSURE ERROR WAS RECEIVED FROM THE PUMP. THE MEDICAL TEAM STATED THAT THE ISSUE WAS NOTED ONLY AFTER THE DEVICE WAS USED IN THE PROCEDURE. THE CORRECT CATHETER SETTINGS HAD BEEN SELECTED ON THE GENERATOR. THERE WERE NO FLOW RATE ISSUES NOTED AT THE START OF THE PROCEDURE. THE CATHETER WAS REPLACED AND THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379779 ↗

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