PENTARAY NAV D128207Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10846835012217), received between Nov 16, 2018 and Jan 28, 2026 — classified as 5 injuries, 10 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 (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT TWO UNITS HAVE BEEN NOTED TO HAVE INCORRECT LABELS. THE INNER POUCH LABEL SHOWS A DIFFERENT PRODUCT CODE THAN THE OUTER BOX LABEL. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203115 ↗
• MalfunctionJan 28, 2026Device Markings/Labelling Problem

  IT WAS REPORTED THAT TWO UNITS HAVE BEEN NOTED TO HAVE INCORRECT LABELS. THE INNER POUCH LABEL SHOWS A DIFFERENT PRODUCT CODE THAN THE OUTER BOX LABEL. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203114 ↗
• MalfunctionJan 29, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND TOWARDS THE END OF THE CASE, IT WAS NOTICED THAT THE CATHETER WAS NO LONGER FLUSHING AT ALL. THE MEDICAL TEAM STATED THAT THE CATHETER WAS ABLE TO BE FLUSHED AT THE BEGINNING OF THE CASE AND DURING THE CASE. THE ISSUE WAS DISCOVERED AFTER COMPLETING ALL LEFT ATRIUM ABLATIONS AND MAPPING. TROUBLESHOOTING WENT AS FOLLOWS: THE MEDICAL TEAM DISCONNECTED AND RECONNECTED IRRIGATION TUBING FROM CATHETER TO ENSURE FLOW THROUGH TUBING. THE PRESSURE IN THE BAG WAS CHECKED. THE ISSUE WAS NOT RESOLVED. THE PHYSICIAN MAPPED THE RIGHT ATRIUM (RA) WITH THE PENTARAY AFTER THE ISSUE WAS DISCOVERED. THE DEVICE WAS NOT REPLACED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21267442 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV AND THE PATIENT EXPERIENCED THROMBOSIS THAT REQUIRED PROLONGED HOSPITALIZATION. A THROMBUS WAS NOTICED DURING THE PROCEDURE. AFTER MAPPING WITH A PENTARAY NAV CATHETER, THE PHYSICIAN NOTICED A THROMBUS/CLOTTING IN THE LEFT ATRIAL APPENDAGE. THEY KEPT AN EYE ON IT ON INTRACARDIAC ECHOCARDIOGRAPHY (ICE) AND CONTINUED THE PROCEDURE. THEY THEN DECIDED TO PULL EVERYTHING OUT OF THE LEFT ATRIUM AND END THE PROCEDURE. THE PATIENT WAS UNDER OBSERVATION AND FURTHER IMAGES WILL BE TAKEN TO DECIDE HOW TO PROCEED. THEY NOTICED THE INJURY ON ICE MIDWAY THROUGH THE PROCEDURE AND CONFIRMED ON THE ULTRASOUND MACHINE. MEDICAL INTERVENTION WAS UNKNOWN, HOWEVER, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AS THE PATIENT WAS SENT TO ANOTHER DEPARTMENT FOR FURTHER INVESTIGATION OF LEFT ATRIAL APPENDAGE (LAA) THROMBUS. IT IS UNKNOWN WHAT CAUSED THE INJURY, HOWEVER, THE PHYSICIAN DID NOT THINK THE INJURY WAS CAUSED BY A CATHETER, BUT WAS JUST NOTICED MIDWAY THROUGH THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20762019 ↗
• InjuryMay 16, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Patient Device Interaction Problem; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WHICH HAD A SPLINE DETACHMENT AND DISLODGED INTO THE PATIENT. DURING THE AFIB CASE, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS RUN THROUGH THE MITRAL MECHANICAL VALVE, AND A SPLINE WAS CUT OFF. THE TIP OF THE SPLINE WITH THE ELECTRODES ON IT WAS LOST, AND IT IS NOW IN A PATIENT'S KIDNEY. IT WAS DISCOVERED VIA THE ELECTRODES AND THEN CONFIRMED BY X-RAY. THERE HAS NOT BEEN ANY PATIENT MEDICAL INTERVENTION YET.

  Patient problems: Foreign Body In Patient

  MAUDE report 19338035 ↗
• MalfunctionApr 11, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND DURING THE PROCEDURE, THE PENTARAY CATHETER WOULD NOT FLUSH AFTER SEVERAL HOURS OF MAPPING. THE CALLER REPORTED THAT THE CATHETER HAD COMPLETE OCCLUSION. TO TROUBLESHOOT, THE CALLER TRIED TO POWER AND USE A SYRINGE TO IRRIGATE IT WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19085796 ↗
• MalfunctionJan 2, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE CATHETER WOULD NOT IRRIGATE. IT WAS REPORTED THAT THE CATHETER WAS TAKEN OUT OF THE PATIENT AND BEFORE IT WAS REINSERTED, THE CATHETER WOULD NOT IRRIGATE. IT WAS REPLACED AND THE NEW CATHETER WOULD IRRIGATE. ADDITIONAL INFORMATION RECEIVED INDICATED THEY TRIED FLUSHING WITH CONNECTED PRESSURE BAG, WOULD NOT DRIP AT BASE OF SPLINES LIKE NORMAL. TOOK SYRINGE & MANUAL FLUSH HAD MUCH RESISTANCE. THE IRRIGATION PORT WAS CONNECTED TO HEPARINIZED PRESSURE BAG BEFORE INSERTION INTO ANY SHEATH AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432084 ↗
• InjuryOct 6, 2022Device-Device Incompatibility; Patient Device Interaction Problem; Device-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A NGEN PUMP, EU CONFIGURATION AND THE PATIENT SUFFERED AN AIR EMBOLISM AND ST SEGMENT ELEVATION. IT WAS REPORTED BY THE CUSTOMER TO THE BIOSENSE WEBSTER INC (BWI) REPRESENTATIVE THAT THEY TRIED TO INSERT THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER INTO A OSCOR'S DESTINO REACH STEERABLE SHEATH, BUT THE CATHETER COULD NOT BE ADVANCED. AFTER SEVERAL ATTEMPTS, THE CUSTOMER DECIDED TO REPLACE THE SHEATH. THE SAME PROBLEM OCCURRED WITH THE NEW SHEATH. AFTER THE SECOND ATTEMPT, THE PATIENT DEVELOPED ST ELEVATIONS WHICH, ACCORDING TO THE CLIENT, WERE PROBABLY CAUSED BY AIR EMBOLIZATION. A SECOND EXAMINER WAS THEN ABLE TO INSERT THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED, THE ST ELEVATIONS WERE FULLY REVERSIBLE, AND THE PATIENT DID NOT RETAIN ANY PERMANENT DAMAGE. THE REASON FOR THIS IS PROBABLY THAT THE FIRST EXAMINER INSERTED THE INSERTION SLEEVE OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER INTO THE SHEATH. THE SECOND EXAMINER THEN ASKED THE BWI REPRESENTATIVE TO SEND HIM THE INSTRUCTIONS FOR USE (IFU) FOR TH

  Patient problems: Air Embolism; Ischemic Heart Disease

  MAUDE report 15548458 ↗
• MalfunctionSep 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A FOREIGN MATERIAL ON USABLE LENGTH OF THE CATHETER WAS OBSERVED. IT WAS REPORTED THAT THERE WAS A PLASTIC FILM ON ONE OF THE SPLINES ON THE CATHETER. THE PHYSICIAN REQUESTED A REPLACEMENT OF THE CATHETER. WHEN THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. THE ISSUE WAS NOTICED BEFORE INSERTION INTO THE BODY. THE BWI REPRESENTATIVE DOES NOT HAVE AN IMAGE OF THE FOREIGN MATERIAL. THE MATERIAL RESEMBLED A FILM. THE PLASTIC BOX WAS DISPOSED OF BUT THEY STILL HAVE THE ORIGINAL BOX AND THE CATHETER. THE FOREIGN MATERIAL WAS THE SIZE OF THE SPLINE AND COVERED ONE ENTIRE SPLINE. THE DEVICE WAS NOT USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15344471 ↗
• MalfunctionMay 31, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PACKAGE HAD A HOLE IN IT. WHEN THE STAFF WAS PULLING PRODUCT FOR THE CASE THEY NOTICED THE CATHETER PACKAGING HAD BEEN COMPROMISED AND HAD A LARGE HOLE. CATHETER WAS SET ASIDE AND NOT USED DUE TO COMPROMISED PACKAGING. NO PATIENT CONSEQUENCES WERE REPORTED. OPEN POUCH SEAL IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14552100 ↗
• InjuryMay 24, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE PATIENT SUFFERED CARDIAC PERFORATION. AFTER THE TRANSSEPTAL PUNCTURE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS NOTED TO BE IN THE PERICARDIUM AND A BLOOD EFFUSION (PERICARDIAL EFFUSION) WAS NOTICED. THE PROCEDURE WAS INTERRUPTED, AND THE CATHETER PULLED OUT OF THE PATIENT'S HEART. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THE ADVERSE EVENT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT TO BE PROCEDURE RELATED. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS REPORTED AS IMPROVED. A TRANSSEPTAL PUNCTURE HAD BEEN PERFORMED WITH A HEART SPAN FROM BIOSENSE WEBSTER. ABLATION WASN¿T PERFORMED, AS SUCH, THE SMARTABLATE GENERATOR WAS NOT USED. IT WAS NOTICED THAT THEY WERE IN THE PERICARDIUM DURING THE MAPPING PHASE. THIS WILL BE CODED AS CARDIAC PERFORATION BECAUSE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS NOTED TO BE IN THE PERICARDIUM. THERE IS NO MENTION OF PERICARDIOCENTESIS OR SURGICAL INTERVENTION.

  Patient problems: Cardiac Perforation

  MAUDE report 14485330 ↗
• MalfunctionFeb 5, 2020Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, AND A POSSIBLE CLOT ISSUE OCCURRED. DURING THE ABLATION PROCEDURE, THE PENTARAY NAV ECO CATHETER WAS NOT IRRIGATING. THE DOCTOR NOTICED THERE WAS BLOOD BACKING UP IN THE PORT. AT THE END OF THE CASE, WHEN HE PULLED THE PENTARAY OUT, HE COULD NOT FLUSH IT. NO CLOT WAS OBSERVED IN OR NEAR THE SPLINES. DUE TO NOT BEING ABLE TO FLUSH THE CATHETER, THE DOCTOR CONCLUDED THERE MUST BE CLOT IN THE INNER LUMEN. NO ERROR MESSAGES WERE OBSERVED ON ANY BIOSENSE WEBSTER INC. (BWI) EQUIPMENT. THE PATIENT WAS ADMINISTERED AN UNKNOWN ANTICOAGULANT DURING THE CASE. THE ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED THROUGHOUT THE CASE AND CHECKED EVERY 15 MINUTES. NO PATIENT CONSEQUENCES WERE REPORTED. THE PATENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS, SINCE THE PROCEDURE WAS COMPLETED. THE OBSERVED IRRIGATION ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9674229 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. DURING THE PROCEDURE, BOTH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WOULD NOT PROPERLY BUILD A MATRIX OF THE LEFT ATRIUM (LA). THE CABLE WAS REPLACED, THE WORK STATION AND PATIENT INTERFACE UNIT (PIU) WERE REBOOTED, AND THE ISSUE REMAINED. POST TRANSSEPTAL, PRIOR TO MAPPING, A CARDIAC TAMPONADE WAS NOTICED AS THE PATIENT'S BLOOD PRESSURE DROPPED. THE PERICARDIAL EFFUSION WAS CONFIRMED BY INTRACARDIAC ECHOCARDIOGRAM (ICE). A PERICARDIOCENTESIS WAS PERFORMED AND 420 CC OF FLUID WAS REMOVED. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PATIENT¿S CONDITION IMPROVED AFTER PERICARDIOCENTESIS, AND THE PATIENT WAS NOTED TO BE FINE. EXTENDED HOSPITALIZATION WAS NOT REQUIRED. PHYSICIAN¿S OPINION ON THE CAUSE OF THE EVENT IS THAT IT WAS CAUSED BY A PRODUCT MALFUNCTION WITH THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER NOT BUILD

  Patient problems: Cardiac Tamponade

  MAUDE report 9279934 ↗
• MalfunctionApr 11, 2019Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR ATRIAL FIBRILLATION (AFIB) WITH A PENTA RAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB (PAL) OBSERVED DAMAGED ELECTRODES AND RINGS ON SPINE C. INITIALLY IT WAS REPORTED THAT A NOISE ISSUE OCCURRED. NOISE ON BOTH THE CARTO 3 SYSTEM AND RECORDING SYSTEM WERE OBSERVED. THE CABLE WAS REPLACED WITH NO RESOLUTION. CATHETER REPLACEMENT RESOLVED THE ISSUE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE NOISE ISSUE HAS BEEN ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE ON 3/18/19, THE BWI PAL RECEIVED THE DEVICE FOR EVALUATION AND DURING A INITIAL VISUAL INSPECTION OBSERVED DAMAGED RINGS ON SPINE C. THE OBSERVED DAMAGED RINGS ON SPINE C HAVE BEEN ASSESSED AS MDR REPORTABLE AS THE DEVICE INTEGRITY WAS COMPROMISED. FURTHER TESTING WAS PERFORMED AND ON 4/5/2019, THE BWI PAL PERFORMED SCANNING ELECTRON MICROSCOPE (SEM) TESTING AND FOUND TWO ELECTRODES DAMAGED AND LIFTED. BOTH THE DAMAGED RINGS ON SPINE C AND DAMAGED ELECTRODES H

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8505875 ↗
• MalfunctionNov 16, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND TIP OF THE CATHETER IS DETACHED REQUIRING EXCESSIVE MANIPULATION TO REMOVE THE CATHETER FROM THE PATIENT¿S BODY. THIS EVENT HAS BEEN ASSESSED AS MDR REPORTABLE. IT WAS REPORTED THAT AS THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS BEING ADVANCED AND POSITIONED INTO THE LEFT ATRIUM FOR AN AFIB PROCEDURE, ONE OF THE SPLINES BECAME ENSNARED IN ONE OF THE SIDE HOLES (IRRIGATION PORTS) ON THE LONG SL1 SHEATH NON-BWI PRODUCT). THE PHYSICIAN WAS UNABLE TO REMOVE THE PENTARAY FROM THE SHEATH. THE SHEATH AND THE CATHETER WERE WITHDRAWN TOGETHER TO PREVENT THE SPLINE FROM BREAKING OFF AND POSSIBLY EMBOLIZING IN THE PATIENT. THE CATHETER WAS REMOVED INTACT; HOWEVER, THERE WAS NOTABLE DAMAGE TO THE SPLINE, ELECTRODES UPON INSPECTION. THE PATIENT HAS NOT EXHIBITING SIGNS OF INJURY OR ADVERSE EVENT. THE PATIENT DID WELL THE NIGHT AFTER THE PROCEDURE AND WAS DISCHARGED WITHOUT ISSUE THE FOLLOWING DAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8079541 ↗

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