OCTARAY Mapping Catheter D160905Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10846835021158), received between Dec 20, 2022 and Sep 30, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (7 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionSep 30, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951568 ↗
• MalfunctionJun 12, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERSISTENT ATRIAL FIBRILLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE IRRIGATION ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON PATIENT. IRRIGATION PUMP CATHETER SHOWED OBSTRUCTION. TRIED TO IRRIGATE MANUALLY OUTSIDE THE PATIENT TO ENSURE THE LUMEN. REPLACED THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 23-MAY-2025. THE SUSPECTED DEVICE FOR THE REPORTED ISSUE WAS THE OCTARAY MAPPING CATHETER. THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON THE PATIENT. DURING THE PROCEDURE, THE PUMP STARTED TO ADVICE ¿HIGH PRESSURE¿. THE BRAND OF THE PUMP USED WAS UNKNOWN, MAYBE BRAUN. STEPS TAKEN TO RESOLVE THE IRRIGATION ISSUE WAS TO REMOVE THE CATHETER, TRY TO IRRIGATE MANUALLY AND REPLACE THE CATHETER. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE PUMP. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF THE ABLATION. THIS EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE ON 23-MAY-2025 OF THE ISSUE WAS NOT NOTED BEFORE THE DEVICE WAS USED ON PATIENT AND HAVE REASSESSED THE EVENT AS REPORTABLE. THE AWARENESS DATE FOR THIS RECORD IS 23-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22197295 ↗
• MalfunctionApr 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT-SIDED ATRIAL FLUTTER PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THE IRRIGATION PUMP SHOWED HIGH PRESSURE. THE MEDICAL TEAM REMOVED THE CATHETER TO IRRIGATE MANUALLY BUT THE LUMEN WAS BLOCKED. THE CATHETER WAS CHANGED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21921533 ↗
• InjuryDec 4, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION, AND THE PATIENT EXPERIENCED CARDIAC PERFORATION THAT REQUIRED SURGICAL INTERVENTION. A CARDIAC TAMPONADE OCCURRED DURING TRANSEPTAL PUNCTURE. THE NEEDLE WENT FROM THE RIGHT ATRIUM (RA) TO THE PULMONARY ARTERY (PA), ALTHOUGH THEY THOUGHT IT WAS THE LEFT ATRIUM (LA). THE OCTARAY MAPPING CATHETER WAS INTRODUCED TO THE PA (THINKING IT WAS LA), AND THE MAP BEGAN. AFTER THE FAST ANATOMICAL MAPPING (FAM) ACQUISITION BEGAN, THEY REALIZED A TAMPONADE OCCURRED AND THE REAL LOCATION OF THE CATHETER, AND SO THE CATHETER WAS REMOVED. THE PATIENT NEEDED A SURGICAL INTERVENTION TO CLOSE THE PERFORATION. THIS EVENT IS MDR REPORTABLE AGAINST THE OCTARAY CATHETER ONLY, AS THE EVENT OCCURRED AFTER THE OCRARAY WAS INTRODUCED INTO THE PULMONARY ARTERY, AND MAPPING WITH THE OCTARAY.

  Patient problems: Cardiac Perforation

  MAUDE report 20840000 ↗
• MalfunctionJul 22, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND AN IRRIGATION ISSUE (DEVICE USED ON THE PATIENT) OCCURRED. FLUSHING FROM OCTARAY MAPPING CATHETER WAS NOT POSSIBLE FOR RE-MAPPING. PHYSICIAN NOTICED THIS ISSUE BEFORE INSERTING THE CATHETER FOR THE SECOND TIME AFTER FIRST MAP. NEW CATHETER NEEDED TO FINISH THE PROCEDURE. NO CONSEQUENCES FOR THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 02-JUL-2024. THE SUSPECTED DEVICE FOR THE REPORTED FLOW/IRRIGATION ISSUE WAS THE CATHETER. WAS NOTED BEFORE INSERTING THE CATHETER FOR FINAL MAP (WAS ALREADY USED BEFORE). NO ERROR. ISSUE DISCOVERED BY THE PHYSICIAN WHILE FLUSHING BEFORE RE-INSERTING. NO GENERATOR INVOLVED (NO ABLATION CATHETER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798036 ↗
• MalfunctionMar 13, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ISCHEMIC CARDIAC ABLATION PROCEDURE WHICH INCLUDED AN OCTARAY MAPPING CATHETER AND THE PHYSICIAN NOTED THAT THE CATHETER DID NOT IRRIGATE ADEQUATELY. THE CATHETER WAS REPLACED. THERE WAS NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED AND IT INDICATED THAT THE ISSUE WAS DISCOVERED WHILE THE DEVICE WAS INSIDE THE PATIENT. AS SUCH, THIS EVENT WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 19-FEB-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18891954 ↗
• MalfunctionJan 1, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND THE OCTARAY CATHETER WAS TAKEN OUT OF THE BODY, THEY NOTICED IT WAS NOT DRIPPING AND APPEARED TO BE CLOGGED. IT WAS REPORTED THAT DURING A PROCEDURE, WHEN THE OCTARAY CATHETER WAS TAKEN OUT OF THE BODY, THEY NOTICED IT WAS NOT DRIPPING AND APPEARED TO BE CLOGGED. TO TROUBLESHOOT THE STAFF TRIED TO POWER FLUSH IT WITHOUT RESOLUTION. THE CATHETER WAS REPLACED, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18423355 ↗
• MalfunctionNov 30, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE AND DURING THE PROCEDURE THE CATHETER WAS NO LONGER ABLE TO FLUSH AFTER THE OCTARAY WAS REMOVED AND THEN REINTRODUCED INTO THE BODY. THE MEDICAL TEAM TRIED TO PRESSURE FLUSH BUT THE ISSUE PERSISTED. THE CATHETER WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239697 ↗
• MalfunctionOct 27, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE. AFTER THE END OF THE PROCEDURE, OCTARAY WAS REMOVED FROM THE PATIENT AND A LARGE THROMBUS WAS ATTACHED TO THE CATHETER. THE ACTIVATED CLOTTING TIME (ACT) WAS IN THERAPEUTIC LEVEL THE WHOLE TIME OCTARAY WAS PRESENT IN THE LEFT ATRIUM (LA). THE OCTARAY AND THE SHEATH WAS FLUSHED WITH HEPARINISED SALINE. A PRESSURE BAG WAS ATTACHED TO THE OCTARAY FLUSH. THE FLUSH WAS NOT OBSTRUCTED. NO ABLATION WAS PERFORMED ON OR CLOSE TO THE OCTARAY. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18024835 ↗
• MalfunctionJul 26, 2023Material Twisted/Bent; Positioning Problem; Material Twisted/Bent; Positioning Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ELECTRODE DAMAGE. IT WAS INITIALLY REPORTED BY THE CUSTOMER THERE WAS NOISE ON ELECTRODES E 1 & 2 OF THE CATHETER DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM WHEN THE CATHETER WAS INSERTED INTO THE BODY. THE CALLER STATED THAT THE DEFLECTION OF THE CATHETER WAS NOT WORKING APPROPRIATELY AND THAT ONE OF THE SPLINES OF THE CATHETER APPEARED TO BE BENT. THE CALLER STATED THAT THE CATHETER WAS UNABLE TO BE FULLY DEFLECTED. THEY REPLACED THE CATHETER, AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT CONSEQUENCE. THE CUSTOMER¿S REPORTED ISSUES OF NOISE, DEFLECTION AND BENT ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL RISK THAT THESE COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. ON 3-JUL-2023, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND ONE OF THE SPLINES WAS OBSERVED WITH SOME ELECTRODES LIFTED. THIS FINDING HAS BEEN REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401765 ↗
• InjuryJun 7, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER. THE PATIENT EXPERIENCED PERICARDIAL EFFUSION REQUIRING SURGICAL INTERVENTION. IT WAS REPORTED THAT THEY WERE MAPPING A TACHYCARDIA, WHEN THE DOCTOR NOTICED BLOOD IN THE PATIENT¿S PERICARDIUM. THE PATIENT HAD TO UNDERGO SURGERY IN ORDER TO STOP THE BLEEDING. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS DISCOVERED DURING USE OF BIOSENSE WEBSTER PRODUCTS. IT WAS DISCOVERED DURING MAPPING WITH THE OCTARAY MAPPING CATHETER. PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. OUTCOME OF THE ADVERSE EVENT WAS IMPROVED. THE PATIENT HAD TO STAY LONGER AT THE HOSPITAL BECAUSE HE UNDERWENT SURGERY TO STOP THE BLEEDING.

  Patient problems: Cardiac Tamponade

  MAUDE report 17079246 ↗
• MalfunctionMay 22, 2023Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THAT THE ELECTRODES #31 AND 32 WERE LIFTED WITH FOREIGN MATERIAL. DURING THE CASE, IT WAS REPORTED THAT THERE WAS NOISE ON ALL SPLINES OF THE OCTARAY CATHETER. TO TROUBLESHOOT, THE CABLES WERE RESEATED WITH NO RESOLUTION. THE CATHETER CABLE WAS REPLACED WITH NO RESOLUTION. UPON REPLACING THE CATHETER, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS CONTINUED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE BAD/PARTIAL ECG WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND FOUND ON 26-APR-2023 THAT ELECTRODES #31 AND 32 WERE LIFTED WITH FOREIGN MATERIAL. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 26-APR-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981616 ↗
• MalfunctionFeb 24, 2023Contamination; Entrapment of Device; Contamination; Entrapment of Device

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE. IT WAS REPORTED THAT WHEN MANIPULATING THE OCTARAY CATHETER TO ACCESS THE RIGHT VENTRICLE, IT APPEARED TO GET STUCK ON THE TRICUSPID ANNULUS. THE OPERATOR COULD FEEL RESISTANCE WHEN ATTEMPTING TO MOVE THE CATHETER. UPON FURTHER INSPECTION USING AN ICE (INTRACARDIAC ECHOCARDIOGRAPHY) CATHETER IT WAS FOUND THAT ONE OR MORE SPLINES SEEMED TO BE ENTANGLED ON THE MEDIAL SEPTAL TRICUSPID ANNULUS. EVENTUALLY AFTER 30 PLUS MINUTES OF MANIPULATING THE CATHETER IN AN ATTEMPT TO FREE IT, IT WAS DISLODGED AND ABLE TO BE PULLED OUT OF THE BODY. INSPECTION OF THE CATHETER ONCE IT WAS PULLED OUT SHOWED A SMALL AMOUNT OF TISSUE WRAPPED AROUND ONE OF THE SPLINES. THE PRODUCT WAS NOT USED IN A CLINICAL TRIAL. CATHETER WAS EVENTUALLY REMOVED FROM THE BODY. THERE WAS A PATIENT IMPACT, AND THE PROCEDURE WAS EXTENDED GREATER THAN 30 MINUTES DUE TO THE DELAY. THERE WAS POTENTIAL MINOR DAMAGE TO THE PATIENT¿S VALVE. THIS WAS INDICATED BY THE SMALL AMOUNT OF TISSUE THAT WAS WRAPPED AROUND AN OCTARAY SPLINE UPON REMOVAL FROM THE PATIENT¿S BODY. THE EVENT IS BEING REPORTED AS AN ADVERSE EVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16440183 ↗
• MalfunctionJan 5, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FILBRILLATION (AFIB) ¿ PAROXYSMAL ABLATION PROCEDURE WITH AN OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE AND AN ELECTRODE DAMAGED WITH FOREIGN MATERIAL ISSUE OCCURRED. IT WAS REPORTED THAT THERE WERE SMALL HAIRS EXTRUDING FROM THE DISTAL END OF THE OCTARAY SPLINE. THE SMALL FIBERS LOOKED LIKE THEY ARE ATTACHED AT THE DISTAL ELECTRODES. THE FIBERS WERE ABOUT 2CM LONG. SURGERY WAS NOT DELAYED DUE TO THE REPORTED EVENT. THE OCTARAY WAS REPLACED WITH A NEW OCTARAY CATHETER AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO PATIENT CONSEQUENCES. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE ELECTRODE DAMAGED WITH FOREIGN MATERIAL ISSUE WAS ASSESSED AS MDR REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109513 ↗
• MalfunctionDec 20, 2022Mechanical Jam; Positioning Problem; Mechanical Jam; Positioning Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN AFIB - PAROXYSMAL ABLATION PROCEDURE WITH A OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE. IT WAS REPORTED THAT THE OCTARAY CATHETER LOST DEFLECTION DURING THE PROCEDURE AND WAS STUCK AT AN 80 DEGREE CURVE. THE CATHETER WAS REPLACED, AND THE ISSUE RESOLVED. THE CASE CONTINUED WITHOUT FURTHER INCIDENT OR HARM. THE CURVE OF THE CATHETER WAS STUCK/JAMMED IN A FULL DEFLECTED POSITION. THE KNOB/PISTON WAS NOT UNABLE TO BE TURNED AND/OR PUSHED UP AND DOWN, YOU COULD STILL MOVE PLUNGER HANGER, BUT CURVE WOULD NOT RELEASE. THERE WAS NO DIFFICULTY IN REMOVING THE CATHETER. THERE WAS NO RING, ELECTRODE OR OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. THEY HAVE ALREADY SENT DEVICE BACK, SO THEY DO NOT HAVE IMAGES. THE SHEATH USED WAS A 8F LONG. DEFLECTION ISSUE IS NOT MDR-REPORTABLE. DEFLECTION STUCK IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16017876 ↗