OCTARAY Mapping CatheterRecalls & reported problems across all models

We found 6 models of OCTARAY Mapping Catheter by Biosense Webster Inc in the FDA's device registry (GUDID). Together they are named in 407 adverse event reports in the FDA's MAUDE database, received between Aug 25, 2021 and Sep 30, 2026 — classified as 3 deaths, 120 injuries, 284 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (133 reports).

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

Most reported OCTARAY Mapping Catheter problems

OCTARAY Mapping Catheter models

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

• OCTARAY Mapping Catheter D160903

  Catheter, intracardiac mapping, high-density array
  146 reports
• OCTARAY Mapping Catheter D160901

  Catheter, intracardiac mapping, high-density array
  1 death113 reports
• OCTARAY Mapping Catheter D160906

  Catheter, intracardiac mapping, high-density array
  2 deaths61 reports
• OCTARAY Mapping Catheter D160904

  Catheter, intracardiac mapping, high-density array
  48 reports
• OCTARAY Mapping Catheter D160902

  Catheter, intracardiac mapping, high-density array
  24 reports
• OCTARAY Mapping Catheter D160905

  Catheter, intracardiac mapping, high-density array
  15 reports

Recent OCTARAY Mapping Catheter adverse event reports

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

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951568 ↗
• InjurySep 23, 2026Patient Device Interaction Problem

  It was reported that a patient underwent a paroxysmal atrial fibrillation ablation with an OCTARAY Mapping Catheter and the patient experienced a pericardial effusion that required Heparin reversed and a pericardiocentesis was performed.Slightly after the transseptal was performed, the patient had a drop in blood pressure and a pericardial effusion was confirmed with Intracardiac Echocardiography (ICE). The medical intervention performed was that Heparin was reversed and a pericardiocentesis was performed. The procedure was aborted. The last known patient status was stable.The physician believed that the pericardial occurred during the transseptal process. The OCTARAY Mapping Catheter had been advanced into the body shortly after transseptal access and that a Left Atrial pre-map was had been performed using the OCTARAY Mapping Catheter. No ablation had been performed. The Smart Touch SF DE catheter was not advanced into the body or used for ablation. The Carto 3 System was used for mapping.Multiple attempts have been made to obtain clarification of this complaint. However, no further information has been made available.

  Patient problems: Cardiac Tamponade

  MAUDE report 50869000 ↗
• MalfunctionSep 23, 2026Obstruction of Flow

  It was reported that a patient underwent an Atrial Fibrillation (AFib) ablation procedure with an OCTARAY Mapping Catheter which was unable to be flushed after ablation. It was reported that there was an irrigation issue involving the OCTARAY catheter. The caller reported that after delivering Pulsed Field Ablation (PFA) with the FARAWAVE PFA CATHETER, they were unable to successfully flush the OCTARAY catheter. They replaced the OCTARAY catheter and the issue was resolved. The procedure continued. There was no patient consequence.Additional information received indicated the suspected device with the issue is the catheter, not the BD Alaris Pump. The catheter was hooked up to a pressure drip, which was working properly, but nothing would flush through the catheter, even trying with a syringe. The device was irrigated properly initially, therefore used on the patient, but it did not irrigate after switching from PFA back to mapping with Octaray Mapping Catheter. There was no error on the pump. The catheter was flushed outside the body before inserting back into the body and it was discovered that it could no longer flush. To troubleshoot, we confirmed that there was flow through th

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867250 ↗
• InjuryAug 11, 2026Failure to Sense; Patient Device Interaction Problem

  It was reported that a patient underwent an atrial fibrillation ablation procedure with a OCTARAY Mapping Catheter and the patient experienced a cardiac tamponade which required pericardiocentesis. While mapping the left atrium, the catheter went into the right atrium without them noticing it. When the catheter went into the coronary sinus (CS), the medical team realized the catheter was no longer in the left atrium. When they tried to go back into the left atrium, they got a lot of resistance from the catheter. At that point, they noticed the Carto 3 System displayed a Magnetic Distortion error on the OCTARAY catheter. Then the patient¿s blood pressure went from stable blood pressure to 43 over 37. The intracardiac echocardiogram (ICE) catheter was pulled from the left atrium into the right atrium and that is when they noticed a large pericardial effusion, so they removed the OCTARAY catheter and the 13 French Agilis sheath from the body. The pericardial effusion was confirmed by ICE (intracardiac echocardiography). Medical intervention provided was pericardiocentesis and 5880cc of fluid was removed before the patient was taken to cardiothoracic (CT) surgery. CT surgeon confirmed

  Patient problems: Cardiac Perforation

  MAUDE report 50216862 ↗
• MalfunctionApr 9, 2026Obstruction of Flow

  IT WAS REPORTED A PATIENT UNDERWENT AN OCTARAY MAPPING CATHETER AND AN IRRIGATION FAILURE OCCURRED. ABOUT 2 HOURS AFTER THE START OF THE PROCEDURE, WHEN REPLACING THE THERMOCOOL® SMART TOUCH® SF CATHETER (STSF) WITH THE OCTARAY MAPPING CATHETER, THE IRRIGATION WAS NOT FUNCTIONING. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. THE PROCEDURE WAS CONTINUED AND COMPLETED WITHOUT PATIENT'S CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED INDICATED IT WAS THE CATHETER THAT WAS BELIEVED TO HAVE THE IRRIGATION ISSUE AND NOT RELATED TO THE GENERATOR. THE ISSUE WAS DETECTED BY VISUAL OBSERVATION AND THE PUMP¿S ERROR ALARM SOUND. THE OCTARAY MAPPING CATHETER WAS REPLACED AND NOT REINSERTED INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837571 ↗
• MalfunctionApr 9, 2026

  NO SIGNALS SEE ON MULTIPLE SPLINES CATHETER REPLACED WITH RESOLUTION OFTHE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829847 ↗
• MalfunctionApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A LIFTED ELECTRODE AND A PLASTIC FIBER ATTACHED TO THE ELECTRODE. INITIALLY, IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, WHEN THEY PULLED OUT THE OCTARAY CATHETER, THEY NOTICED A PLASTIC STRINGLIKE PIECE ATTACHED TO THE BASE OF THE SPLINES. UNRAVELED LIKE A SWEATER UNRAVELED. THEY HAD NO ISSUES WITH THE CATHETER DURING THE PROCEDURE. NO PATIENT CONSEQUENCE REPORTED. THE CATHETER WAS BRAND NEW FROM BIOSENSE WEBSTER, INC. BOX PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED. DOES NOT BELIEVE THAT THERE WERE WIRES EXPOSED. DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THE PHYSICIAN NEVER MENTIONED ANY RESISTANCE. IT WAS NOT KNOWN IF THE DEVICE WAS PRE-SHAPED. THE PLASTIC STRINGLIKE PIECE ISSUE WAS ASSESSED AS MDR REPORTABLE UNDER THE VIZIGO SHEATH REPORTED UNDER MANUFACTURER REPORT NUMBER 2029046-2026-00581. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE OCTARAY MAPPING CATHETER FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 09-MAR-2026, FOUND A LIFTED ELECTRODE IN ONE OF THE SPLINES,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776369 ↗
• MalfunctionMar 26, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE FOR PREMATURE VENTRICULAR CONTRACTIONS (PVCS) AND THE IRRIGATION OF THE OCTARAY MAPPING CATHETER APPEARED COMPLETELY BLOCKED. VISUALLY, THERE WAS NO IRRIGATION OUTLET. THEY FORCE PURGED OUTSIDE OF THE BODY WITH SODIUM CHLORIDE (NACL) SYRINGE. USING A PRESSURIZED SYRINGE DID NOT RESTORE THE SALINE FLOW. A NEW CATHETER WAS USED FOR THE SECOND PART OF THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER A DELAY OF TEN MINUTES. THE DEVICE WAS USED IN THE PATIENT. THE ISSUE WAS IDENTIFIED DURING THE SECOND PART OF MAPPING, ON THE SECOND INTRODUCTION OF THE CATHETER. THERE WERE NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF ABLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24695473 ↗
• InjuryMar 25, 2026Device-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED HYPOTENSION AND BLEEDING THAT REQUIRED BLOOD TRANSFUSION. IT WAS REPORTED THAT THEY WERE ADVANCING THE FARAWAVE¿ PFA CATHETER BACK INTO THE BODY WHEN THE ANESTHESIOLOGIST STATED THE PATIENT BLOOD PRESSURE HAS DROPPED (50/40). THE PROCEDURE WAS STOPPED. THE PATIENT'S HEMOGLOBIN WAS CHECKED, AND IT ALSO DROPPED (3-4 POINTS). XRAY AND CONTRAST WERE USED TO LOCATE THE BLEED, THEY WERE UNSUCCESSFUL AND THE PATIENT WAS TAKEN TO A CT SCAN (COMPUTED TOMOGRAPHY). THE MEDICAL INTERVENTION WAS ADMINISTERING BLOOD; HOWEVER, IT WAS UNKNOWN IF ANY MEDICATIONS WERE GIVEN. THE PATIENT LAST KNOWN STATUS WAS STABLE AND INTUBATED. EARLIER IN THE CASE, THEY WERE UNCERTAIN AND WORRIED THAT THERE MAY HAVE BEEN A PERFORATION WHEN THEY HAD TROUBLE ADVANCING THE OCTARAY¿ CATHETER. IT KEPT GETTING STUCK, SO IT WAS REMOVED. THEY THEN ATTEMPTED TO ADVANCE THE WIRE AND THEY EXPERIENCED DIFFICULTY. THE SHEATH WAS REPLACED AND THEY WERE ABLE TO ADVANCE THE WIRE. THE PHYSICIAN WAS UNSURE ON THE CAUSE OF THE EVENT. HE THOUGHT IT MAY HAVE OCCURRED EARLY IN THE CASE WHEN HE WAS HAVING DIFFICULTY ADVANCING THE OCTARAY

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 24691045 ↗
• MalfunctionMar 24, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND APPROXIMATELY 3 HOURS AFTER CATHETER INSERTION INTO THE PATIENT¿S BODY, NOTICED THAT OCTARAY IRRIGATION WAS NOT PERFORMING. THE MEDICAL TEAM ATTEMPTED TO FLUSH WITH THE SYRINGE, BUT IT WAS STIFF AND FLUSHING COULD NOT BE PERFORMED. BECAUSE THERE WAS A RISK FOR THROMBUS FORMATION, A NEW CATHETER WAS OPENED, THE NEW CATHETER FLUSHED WITHOUT ISSUE, AND THE PROCEDURE WAS CONTINUED. THE PROCEDURE WAS COMPLETED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24681503 ↗
• InjuryMar 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. AFTER PRE-MAPPING THE LEFT ATRIUM, DECREASE IN PATIENT¿S BLOOD PRESSURE WAS OBSERVED, AND PERICARDIAL EFFUSION WAS CONFIRMED WITH ECHOCARDIOGRAPHY. PERICARDIOCENTESIS WAS PERFORMED, THE PATIENT¿S VITAL BECAME STABLE, AND THE PROCEDURE WAS TERMINATED. PATIENT IMPROVED. THERE WAS A POSSIBILITY THAT IT OCCURRED AFTER BB OR DURING LEFT ATRIUM ACCESS. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. THERE WAS NO EVIDENCE OF STEAM POP. PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 350 SECONDS. NO ABLATIONS WERE PERFORMED. THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION.

  Patient problems: Cardiac Tamponade

  MAUDE report 24639462 ↗
• MalfunctionMar 18, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER. AN ERROR OCCURRED IN THE PERFUSION PUMP WHEN ATTEMPTING TO PERFORM POST MAPPING. THE ERROR INDICATED THAT PERFUSION WAS NOT FUNCTIONING PROPERLY, AND THE DRIP RATE FROM THE CATHETER WAS LESS THAN DURING PRE-MAPPING. THEREFORE, THE CATHETER WAS REPLACED AT THE DOCTOR'S DISCRETION. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE IS THE CATHETER. A HOSPITAL-OWNED INFUSION PUMP WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24630844 ↗
• MalfunctionMar 17, 2026Failure to Advance

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE INTRODUCER BECAME TRAPPED IN SHEATH HUB, REQUIRING REMOVAL OF INTRODUCER WITH FORCEPS. THERE WERE NO ISSUES WITH LOADING OR ADVANCING INTO THE DELIVERY SHEATH, NO LEAKING ISSUES, NO CHAR OR DEVICE EMBOLIZATION. NO DEFLECTION ISSUES. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24624417 ↗
• MalfunctionMar 16, 2026Contamination /Decontamination Problem; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIOVENTRICULAR NODAL REENTRANT TACHYCARDIA (AVNRT) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER WHICH HAD A PIECE OF PLASTIC COME OUT WITH IT UPON REMOVAL FROM THE PATIENT. IT WAS REPORTED BY THE CUSTOMER THAT WHILE ADVANCING WITH THE OCTARAY¿ CATHETER, IT "DID NOT GO UP." THE BWI REPRESENTATIVE REPORTED THAT AFTER PULLING BACK THE OCTARAY¿ CATHETER, A PIECE OF PLASTIC CAME WITH IT AND THE SPLINE WAS ALSO BENT. THE BWI REPRESENTATIVE REPORTED THAT THE PHYSICIAN DECIDED TO CONTINUE MAPPING WITH THE QDOT MICRO¿ CATHETER. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. THE OCTARAY MAPPING CATHETER WAS USED WITH A SHEATH WAS PINNACLE TERUMO 8FR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607850 ↗
• MalfunctionMar 13, 2026Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND OBSERVED THE CATHETER DID NOT FLUSH (DEVICE WAS USED IN THE PATIENT). THE OCTARAY¿ CATHETER DID NOT FLUSH WITH PRESSURE LINE. THE CATHETER WAS REPLACED AND THE ISSUE RESOLVED. THE CALLER NOTED THAT IT WAS A BRAND NEW CATHETER. THE PROCEDURE CONTINUED WITH NO FURTHER ISSUES. UNABLE TO CONFIRM THE GENERATOR USED. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 18-FEB-2026. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER BASED UPON THE INFORMATION REPORTED. THE DEVICE WAS USED IN THE PATIENT. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS REPLACED THE CATHETER AND THEN COMPLETED THE PROCEDURE. THE CATHETER ¿DID NOT FLUSH¿ ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 18-FEB-2026 THAT THE DEVICE WAS USED IN THE PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 18-FEB-2026 BECAUSE THE CATHETER DID NOT FLUSH (DEVICE WAS USED IN THE PATIENT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24595760 ↗

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