IntellaNav™ Open-Irrigated M004R9620K20Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729937449), received between Feb 21, 2017 and Sep 28, 2020 — classified as 2 deaths, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P150005); 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2020Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT A INTELLANAV OPEN-IRRIGATED WAS USED IN A ATRIAL TACHYCARDIA PROCEDURE. IT WAS NOTED THAT DURING THE PROCEDURE NOISY ELECTRODES OCCURRED. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS BEING REPORTED. HOWEVER ANALYSIS OF THE RETURNED DEVICE REVEALED TWO LEAKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10594080 ↗
• MalfunctionAug 8, 2019Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT STEAM POP OCCURRED. DURING AN ABLATION FOR ATRIAL TACHYCARDIA IN THE RIGHT ATRIUM, A STEAM POP OCCURRED WITH THE INTELLANAV OPEN IRRIGATED CATHETER NEAR THE CORONARY SINUS OSTIUM. THE PATIENT'S BLOOD PRESSURE REMAINED NORMAL. THE SUSPECTED CAUSE WAS THAT THE PHYSICIAN WAS ABLATING ON THIS ANATOMY STRUCTURE. HIGH FLOW WAS SET FOR 30 WATTS OR MORE AND LOW FLOW FOR LESS THAN 30 WATTS. IMPEDANCE VALUES WERE UNKNOWN. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8875200 ↗
• DeathMar 6, 2019Material Deformation; Material Deformation

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE ILIAC ARTERY WAS PERFORATED, AND THE PATIENT EXPERIENCED A RETROPERITONEAL BLEED AND HEMATOMA. SYMPTOMS SECONDARY TO BLOOD LOSS INCLUDED: LOW BLOOD PRESSURE, ST SEGMENT ELEVATION, TWITCHING OF THE RIGHT CORONARY ARTERY, AND INCESSANT VENTRICULAR TACHYCARDIA (VT). AN INTELLAMAP ORION MAPPING CATHETER, AN INTELLANAV OI ABLATION CATHETER, AND ANOTHER MANUFACTURER'S SHORT SHEATH WERE SELECTED FOR USE DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE. ACCESS WAS GAINED IN THE LEFT AND RIGHT FEMORAL VEINS AND THE RIGHT FEMORAL ARTERY, WITH ULTRASONIC GUIDANCE. A SHORT SHEATH WAS PLACED IN THE FEMORAL ARTERY AND THE MAPPING CATHETER WAS ADVANCED WITHOUT ISSUE. AFTER MAPPING FOR ABOUT 20 MINUTES THE CATHETER WAS REMOVED, ALSO WITHOUT ISSUE. THE INTELLANAV OI ABLATION CATHETER WAS THEN INSERTED INTO THE SHEATH, AND THE PHYSICIAN FELT RESISTANCE. INITIALLY IT WAS REPORTED THAT THE PHYSICIAN REALIZED ON FLUOROSCOPY THAT THE CATHETER HAD A KINK IN IT; HOWEVER, IT WAS LATER REPORTED THAT THE CATHETER HAD BEEN KINKED PRIOR TO INSERTION INTO THE PATIENT'S BODY. DUE TO THE KINK, THE PHYSICIAN REQUESTED A NEW ABLATION CATHETER. AT THAT TIME,

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels; ST Segment Elevation; Vasoconstriction; Ventricular Tachycardia

  MAUDE report 8394326 ↗
• DeathMar 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT DEATH OCCURRED. THE ILIAC ARTERY WAS PERFORATED, AND THE PATIENT EXPERIENCED A RETROPERITONEAL BLEED AND HEMATOMA. SYMPTOMS SECONDARY TO BLOOD LOSS INCLUDED: LOW BLOOD PRESSURE, ST SEGMENT ELEVATION, TWITCHING OF THE RIGHT CORONARY ARTERY, AND INCESSANT VENTRICULAR TACHYCARDIA (VT). AN INTELLAMAP ORION MAPPING CATHETER, AN INTELLANAV OI ABLATION CATHETER, AND ANOTHER MANUFACTURER'S SHORT SHEATH WERE SELECTED FOR USE DURING AN ISCHEMIC VENTRICULAR TACHYCARDIA ABLATION PROCEDURE. ACCESS WAS GAINED IN THE LEFT AND RIGHT FEMORAL VEINS AND THE RIGHT FEMORAL ARTERY, WITH ULTRASONIC GUIDANCE. A SHORT SHEATH WAS PLACED IN THE FEMORAL ARTERY AND THE MAPPING CATHETER WAS ADVANCED WITHOUT ISSUE. AFTER MAPPING FOR ABOUT 20 MINUTES THE CATHETER WAS REMOVED, ALSO WITHOUT ISSUE. THE INTELLANAV OI ABLATION CATHETER WAS THEN INSERTED INTO THE SHEATH, AND THE PHYSICIAN FELT RESISTANCE. INITIALLY IT WAS REPORTED THAT THE PHYSICIAN REALIZED ON FLUOROSCOPY THAT THE CATHETER HAD A KINK IN IT; HOWEVER, IT WAS LATER REPORTED THAT THE CATHETER HAD BEEN KINKED PRIOR TO INSERTION INTO THE PATIENT'S BODY. DUE TO THE KINK, THE PHYSICIAN REQUESTED A NEW ABLATION CATHETER. AT THAT TIME,

  Patient problems: Death; Hematoma; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels; ST Segment Elevation; Vasoconstriction; Ventricular Tachycardia

  MAUDE report 8394290 ↗
• MalfunctionOct 10, 2018Electrical /Electronic Property Problem; Leak/Splash; Material Integrity Problem; Electrical /Electronic Property Problem; Leak/Splash; Material Integrity Problem

  IT WAS REPORTED THAT NO MAGNETIC SENSOR DETECTING WAS NOTED DURING THE CREATION OF THE 3D MAP. ALSO LEAKING CONNECTORS AND A BEND IN THE CATHETER WAS OBSERVED. DURING LEFT VENTRICULAR ABLATION, THE INTELLANAV OPEN-IRRIGATED CATHETER DID NOT HAVE MAGNETIC SENSOR DETECTION DURING THE CREATION OF THE 3D MAP. WHEN THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY, LEAKING CONNECTORS AND A BEND IN THE CATHETER WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CURRENT CONDITION IS FINE. VISUAL INSPECTION REVEALED THAT THE DISTAL END OF THE CATHETER IS BENT IN TWO PLACES; IMMEDIATELY DISTAL FROM THE BUTT BOND AND ANOTHER NEAR THE DISTAL TIP. THE BUTT BOND SEAL IS SPLIT AROUND THE ENTIRE CIRCUMFERENCE OF THE MAIN BODY TUBING AND HAS BODY FLUID INGRESS. DRIED BODY FLUID WAS FOUND ON THE HANDLE, MAIN BODY TUBING, DISTAL END, AND INSIDE THE CONNECTOR PIN SOCKETS. DRIED SALINE WAS ALSO FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. ELECTRICAL CONTINUITY CHECKED REVEALED NO ELECTRICAL SHORTS. THE TIP MEASURED ELECTRICALLY OPEN. ALL OTHER ELECTRODES, SENSOR AND THERMOCOUPLE RESISTANCES MEASURED IN SPEC AND WERE TYPI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951388 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS 2134265-2018-60443. IT WAS REPORTED A PERICARDIAL EFFUSION AND POSSIBLE PERFORATION OCCURRED. AN INTELLAMAP ORION MAPPING CATHETER AND AN INTELLANAV OI ABLATION CATHETER WERE SELECTED FOR USE DURING AN ATRIAL FIBRILLATION AND ATRIAL FLUTTER REDO ABLATION PROCEDURE. AFTER THE LEFT ATRIAL MAP WAS COMPLETED, THE ORION WAS LEFT IN THE LEFT ATRIUM. AN INTELLANAV OI WAS PLACED INTO THE LEFT ATRIUM USING A ZURPAZ SHEATH. AT THAT TIME, THE PATIENT'S BLOOD PRESSURE DROPPED CONSIDERABLY. ECHOCARDIOGRAPHY WAS CALLED; THERE WAS FLUID IN THE PERICARDIAL SPACE. THE CATHETERS AND SHEATHS WERE REMOVED FROM THE LEFT ATRIUM DUE TO PERICARDIAL EFFUSION. A SIGNIFICANT AMOUNT OF BLOOD WAS DRAINED FROM THE PERICARDIAL SPACE AND THE PATIENT WAS SENT TO THE OPERATING ROOM DUE TO BLEEDING AND FOR POSSIBLE SURGERY. IT WAS DETERMINED THE BLEEDING INTO THE PERICARDIAL SPACE FIXED ITSELF. THE REST OF THE BLEEDING WAS DUE TO THE DRAIN THAT WAS PLACED HITTING THE LIVER. THE PATIENT WAS EXPECTED TO FULLY RECOVER. THERE HAD NOT BEEN ANY DEVICE ISSUES DURING THE PROCEDURE. THE PHYSICIAN SUSPECTED A POSSIBLE PERFORATION WHILE MAPPING IN THE LEFT ATRIUM WITH THE ORION; HOWEVER, HE WASN'T SURE.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 7842539 ↗
• MalfunctionJul 11, 2018Deformation Due to Compressive Stress; Communication or Transmission Problem; Deformation Due to Compressive Stress; Communication or Transmission Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20JUNE2018. A INTELLANAV OI WAS SELECTED FOR A 3D COMPLEX ELECTROPHYSIOLOGY PROCEDURE. IT WAS REPORTED THAT CATHETER KINKING AND NAVIGATION FAILURE OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER ANALYSIS REVELED SEAL BREAK AND BUTT BOND FAILURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7677559 ↗
• InjuryMar 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS 2134265-2018-02371. IT WAS REPORTED ST ELEVATION AND A LIKELY AIR EMBOLISM OCCURRED. DURING ABLATION WITH AN INTELLANAV OI ABLATION CATHETER, THE BUBBLE DETECTOR ON THE METRIQ PUMP ALARMED. THE BUBBLE WAS ADDRESSED BY STOPPING ABLATION, REMOVING THE CATHETER FROM THE BODY, DISLODGING ANY BUBBLES IN THE PUMP TUBING, AND FLUSHING THE CATHETER WITH 75 ML. THE PUMP WAS THEN PLACED IN STANDBY FLOW AND REINSERTED INTO THE BODY. THE PHYSICIAN NOTICED ST ELEVATION AND A DROP IN BLOOD PRESSURE; IT WAS UNCLEAR IF THIS OCCURRED BEFORE OR DURING INITIAL ABLATION. THE PHYSICIAN INDICATED IT WAS LIKELY AN AIR EMBOLISM. THE PATIENT WAS EXAMINED USING ULTRASOUND, BUT NO FURTHER INTERVENTIONS TOOK PLACE. THE CATHETER WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER BOSTON SCIENTIFIC ABLATION CATHETER. THE CASE ENDED SUCCESSFULLY AND THE PATIENT LEFT THE ROOM IN STABLE CONDITION.

  Patient problems: Air Embolism; ST Segment Elevation

  MAUDE report 7372812 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-01569 AND 2134265-2018-01566. IT WAS REPORTED AN AIR BUBBLE WAS INTRODUCED INTO THE PATIENT¿S HEART. AN INTELLANAV MIFI XP ABLATION CATHETER WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION PROCEDURE. HOWEVER, THE AREA OF THE HEART THAT WAS BEING TREATED WAS A LOW BLOOD FLOW AREA WHICH EQUATED TO LOW POWER DELIVERY; TO RESOLVE THIS ISSUE THE PHYSICIAN SWITCHED TO AN IRRIGATED CATHETER AND SELECTED AN INTELLANAV OI WITH A METRIQ IRRIGATION PUMP AND TUBING SET. THE CATHETER WAS PREPPED AND FLUSHED WITH NEARLY 80ML THROUGH THE PUMP. ALMOST IMMEDIATELY AFTER ABLATION BEGAN, THE MAESTRO 4000 GENERATOR HALTED AND DISPLAYED AN ERROR MESSAGE. IN AN EFFORT TO TROUBLESHOOT THE ERROR MESSAGE, THE CATHETER WAS REPLACED WITH ANOTHER INTELLANAV OI. THE SECOND CATHETER WAS FLUSHED WITH THE PUMP FOR APPROXIMATELY 50ML OF SALINE. HOWEVER, THE ISSUE PERSISTED. THE CATHETER WAS REMOVED FROM THE PATIENT, THE PUMP WAS POWERED OFF, AND THE CABLE BETWEEN THE PUMP AND GENERATOR WAS REPLACED WHICH RESOLVED THE ISSUE. POWER WAS TURNED BACK ON, THE PURGE BUTTON WAS HELD DOWN FOR A FEW SECONDS, STANDBY FLOW MODE WAS SELECTED AT 2ML/MIN, AND THE PUMP WAS DEEMED TO BE FUNCTIO

  Patient problems: Air Embolism; ST Segment Elevation

  MAUDE report 7315939 ↗
• MalfunctionJan 31, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT CATHETER SEPARATION OCCURRED. DURING AN ABLATION PROCEDURE, THE INTELLANAV OI ABLATION CATHETER SHOWED HIGH TEMPERATURES DURING USE; HIGH TEMPERATURE ERRORS WERE DISPLAYED ON THE MAESTRO GENERATOR. UPON REMOVING THE CATHETER FROM THE PATIENT, IT WAS DISCOVERED THAT THE DISTAL SHAFT SECTION HAD BECOME SEPARATED FROM THE PROXIMAL SHAFT SECTION. THE PROCEDURE WAS COMPLETED USING ANOTHER CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7230161 ↗
• MalfunctionDec 14, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT STEAM POP OCCURRED. THE INTELLANAV OI WAS SELECTED FOR AV NODE ABLATION. ABLATION SETTINGS WERE 30W WITH 17 ML/MIN FLOW RATE. NO OBVIOUS IMPEDANCE OR TEMP RISE WAS NOTED. HOWEVER A STEAM POP WAS NOTED, THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. PATIENT BLOOD PRESSURE WAS MONITORED POST PROCEDURE WITH NO OBVIOUS SIGN OF TAMPONADE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7118873 ↗
• MalfunctionNov 8, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT DURING AN ABLATION PROCEDURE, CATHETER IRRIGATION PORTS WERE NOT IRRIGATING PROPERLY. AN INTELLANAV OI ABLATION CATHETER WAS USED DURING A PROCEDURE TO TREAT FLUTTER. FOLLOWING DELIVERY OF ABLATION ENERGY, ¿EVENTUALLY¿ THE IRRIGATION PUMP ALARMED AND INDICATED AN OCCLUSION DOWNSTREAM. IT WAS VERIFIED THAT EVERYTHING WAS WORKING CORRECTLY AND AN ATTEMPT WAS MADE TO CONTINUE THE PROCEDURE; HOWEVER, THE ALARM INDICATING OCCLUSION OCCURRED AGAIN. THE CATHETER WAS REMOVED FROM THE BODY AND IT WAS VISUALLY OBSERVED THAT THE IRRIGATION PORTS WERE NOT ALL IRRIGATING PROPERLY. IT WAS UNKNOWN HOW MANY OF THE PORTS WERE NOT IRRIGATING, BUT SOME PORTS WERE PRODUCING SEEMINGLY NORMAL STREAMS OF IRRIGATION, WHILE OTHERS WERE NOT. THE PHYSICIAN INSPECTED THE CATHETER AND WIPED THE TIP, BUT IRRIGATION DID NOT IMPROVE. ANOTHER INTELLANAV OI WAS USED TO COMPLETE THE PROCEDURE, AND IT WAS NOTED THE DIFFERENCE IN IRRIGATION SPRAY WAS SIGNIFICANT. THERE WERE NO PATIENT COMPLICATIONS; THE PATIENT WAS ¿FINE.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7009790 ↗
• MalfunctionAug 23, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS FOUND ON THE DEVICE. DURING PREPARATION OUTSIDE THE PATIENT THE INTELLANAV OI HAD A GREEN PIECE OF PLASTIC STUCK TO THE SHAFT APPROXIMATELY 10 TO 20 CM BACK FROM THE DISTAL TIP. THE CATHETER WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INTELLANAV OI. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6813794 ↗
• MalfunctionFeb 21, 2017Material Separation; Material Separation

  IT WAS REPORTED THAT THERE WAS A SEPARATION OF A SEGMENT OF THE CATHETER. DURING A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH AN INTELLANAV OI ABLATION CATHETER, A SEPARATION OF A SEGMENT OF THE CATHETER OCCURRED IN THE PATIENT'S LEFT VENTRICLE. IT DIDN'T COMPLETELY COME APART FROM THE CATHETER, BUT THERE WAS A SEPARATION IN THE SHAFT'S MATERIAL OF THE CATHETER NEAR THE UPPER DISTAL THIRD OF THE CATHETER. AFTER THE SEPARATION, TWO ALARMS OCCURRED. THE FIRST ALARM WAS THEY LOST CATHETER VISUALIZATION DURING ABLATION ON THE RYTHMIA SYSTEM. THE SECOND ALARM WAS A HIGH IMPEDANCE ALARM NOTED ON THE MAESTRO 4000 RF GENERATOR. THERE WAS ALSO NOISE ON THE DISTAL ABLATION SIGNALS. NO PATIENT COMPLICATIONS OCCURRED. THE PROCEDURE WAS NOT COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6346006 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150005. One submission often covers many models, so check the product and lot details in each record.

• Z-0699-2019 · Nov 28, 2018 · Open, Classified
  Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump