IntellaTip MiFi™ Open-Irrigated M004PM96200Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729848684), received between Aug 23, 2017 and Nov 21, 2023 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Temperature Problem” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Temperature Problem; Temperature Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT ATRIAL FIBRILLATION (A FIB) USING A INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER THE CATHETER DID NOT ACCURATELY DISPLAY TEMPERATURE. THE DEVICE WAS DISPLAYING 25C INSTEAD OF DISPLAYING BODY TEMPERATURE WHEN IT WAS INTRODUCED INTO THE BODY. THEY REPLACED THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS. THE CATHETER IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED BY THE FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187356 ↗
• MalfunctionMar 24, 2020Failure to Deliver Energy; Device Displays Incorrect Message; Failure to Deliver Energy; Device Displays Incorrect Message

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26FEB2020. IT WAS REPORTED THAT THE CATHETER COULD NOT APPLY CURRENT. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FLUTTER IN THE HEART A INTELLATIP MIFI OPEN-IRRIGATED CATHETER WAS SELECTED FOR USE. WHEN ENERGIZATION WAS PERFORMED, THE TEMPERATURE WAS DISPLAYED AS LO, AND COULD NOT APPLY CURRENT, THEREFORE THE CATHETER WAS REPLACED AND THE ABLATION WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE RING 1 PROXIMAL SEAL WAS PARTIALLY SEPARATED FROM THE ELECTRODE ALLOWING FLUID TO ENTER INTO THE DISTAL END CAVITY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9873221 ↗
• MalfunctionJan 9, 2020Device Displays Incorrect Message; Device Displays Incorrect Message

  REPORTABLE BASED N DEVICE ANALYSIS COMPLETED ON 13DEC2019. IT WAS REPORTED THAT THE CATHETER WOULD NOT INITIATE STANDBY FLOW. DURING AN ABLATION PROCEDURE, THE INTELLATIP MIFI OPEN-IRRIGATED CATHETER WOULD NOT INITIATE STANDBY FLOW AFTER PREVIOUSLY WORKING WITH NO ISSUE. AFTER CLEARING THE RESULTING ALARM AND ERROR MESSAGE MULTIPLE TIMES, STANDBY FLOW WOULD STILL NOT INITIATE. THE CATHETER WAS REMOVED FROM THE PATIENT, THE CATHETER CABLE WAS DISCONNECTED, AND THE PUMP WAS REPLACED, BUT THE ISSUE PERSISTED. THE CATHETER WAS EXCHANGED, WHICH SOLVED THE ISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS. DEVICE ANALYSIS REVEALED TWO IRRIGATION PORTS WERE OCCLUDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569113 ↗
• MalfunctionSep 5, 2019Device Displays Incorrect Message; Temperature Problem; Device Displays Incorrect Message; Temperature Problem

  IT WAS REPORTED THAT THE TEMPERATURE OF THE CATHETER REMAINED CONSTANT AT 85 DEGREES CELSIUS. DURING AN ABLATION PROCEDURE FOR SUPRAVENTRICULAR TACHYCARDIA (WOLFF-PARKINSON-WHITE SYNDROME), THE TEMPERATURE OF THE INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER BECAME CONSTANT AT 85 DEGREES CELSIUS, MAKING IT IMPOSSIBLE TO CONTINUE WITH THE ABLATION. THE PHYSICIAN WAS ATTEMPTING TO ABLATE A SEPTAL KENT IN THE LEFT ATRIUM. IT WAS DECIDED TO REPLACE THE CATHETER AND AS THE PHYSICIAN ALSO SUSPECTED A RIGHT SEPTAL KENT, IT WAS DECIDED TO SWITCH TO A BLAZER II CATHETER, WHICH PERFORMED NORMALLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8964837 ↗
• MalfunctionAug 29, 2019Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-AUG-2019. IT WAS REPORTED THAT A NOISY ELECTROGRAM OCCURRED. DURING AN ABLATION PROCEDURE FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) WITH AN INTELLATIP MIFI OPEN-IRRIGATED (OI) CATHETER, WHILE IN THE RIGHT ATRIUM NOISE OCCURRED IN THE TIP ELECTRODE 1-2 AFTER THE CATHETER WAS INSERTED INTO THE BODY. THE CABLE WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. A NEW INTELLATIP MIFI OI CATHETER WAS USED AND NOISE IN ALL ELECTRODES WERE ALSO NOTED. THE PERIPHERAL EQUIPMENT WAS TURNED OFF, AND CABLES WERE ARRANGED, AND THE ARRANGEMENT OF CONNECTION BOX WAS CHANGED, BUT THE ISSUE WAS NOT RESOLVED AT ALL. THE POSITION OF THE RETURN ELECTRODE WAS CHANGED, AND TRIED PACING FROM THE CATHETER, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC CATHETER. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, DEVICE ANALYSIS SHOWED FLUID INGRESS INSIDE THE DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947185 ↗
• MalfunctionAug 29, 2019Poor Quality Image; Poor Quality Image

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07-AUG-2019. IT WAS REPORTED THAT A NOISY ELECTROGRAM OCCURRED. DURING AN ABLATION PROCEDURE FOR PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT) WITH AN INTELLATIP MIFI OPEN-IRRIGATED (OI) CATHETER, WHILE IN THE RIGHT ATRIUM NOISE OCCURRED IN THE TIP ELECTRODE 1-2 AFTER THE CATHETER WAS INSERTED INTO THE BODY. THE CABLE WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. A NEW INTELLATIP MIFI OI CATHETER WAS USED AND NOISE IN ALL ELECTRODES WERE ALSO NOTED. THE PERIPHERAL EQUIPMENT WAS TURNED OFF, AND CABLES WERE ARRANGED, AND THE ARRANGEMENT OF CONNECTION BOX WAS CHANGED, BUT THE ISSUE WAS NOT RESOLVED AT ALL. THE POSITION OF THE RETURN ELECTRODE WAS CHANGED, AND TRIED PACING FROM THE CATHETER, BUT THE ISSUE WAS NOT RESOLVED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC CATHETER. NO PATIENT COMPLICATIONS OCCURRED. HOWEVER, DEVICE ANALYSIS SHOWED FLUID INGRESS INSIDE THE DISTAL TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8947130 ↗
• MalfunctionJan 31, 2019Communication or Transmission Problem; Communication or Transmission Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED JANUARY 8, 2019. AN INTELLATIP MIFI OI ABLATION CATHETER WAS SELECTED FOR USING DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, ALL POTENTIALS COULD NOT BE FOUND; IT SEEMED THAT ELECTRICAL LOSS OCCURRED. THE CATHETER WAS REPLACED AND THE PROCEDURE WAS PERFORMED WITHOUT FURTHER ISSUES. HOWEVER, RETURNED DEVICE ANALYSIS FOUND OBSTRUCTED IRRIGATION PORTS. THE OBSTRUCTION WAS SUSPECTED TO BE DRIED SALINE; HOWEVER, THE OBSTRUCTION HAD NOT BEEN LOCATED DURING ANALYSIS. DURING RETURNED DEVICE ANALYSIS, THE DEVICE PASSED ALL ELECTRICAL TESTING. THERE WERE NO ELECTRICAL SHORTS OR OPENS; ALL ELECTRODES, SENSOR, AND THERMOCOUPLE RESISTANCE MEASUREMENTS WERE WITHIN SPECIFICATION. THE STEERING KNOB AND TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH THE LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACTUATING THE STEERING MECHANISM. ABLATION WAS ATTEMPTED; HOWEVER, AN "OCCLUSION DETECTED" ERROR OCCURRED IMMEDIATELY AFTER THE PUMP WAS STARTED. ABLATION WAS PERFORMED ON THE BENCH WITHOUT IRRIGATION CONNECTED, AND THE DEVICE WAS FOUND WITHIN SPECIFICATION. THE HANDLE WAS CUT OPEN TO INS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8293707 ↗
• MalfunctionJan 2, 2019Failure to Deliver Energy; Temperature Problem; Failure to Deliver Energy; Temperature Problem

  IT WAS REPORTED THAT A TEMPERATURE ISSUE OCCURRED. DURING AN ABLATION PROCEDURE INVOLVING A INTELLATIP MIFI OPEN IRRIGATED CATHETER, THE CATHETER WAS INSERTED INTO THE BODY, AND THE PHYSICIAN TRIED TO PERFORM ENERGIZATION, BUT THE TEMPERATURE BECAME 60 DEGREES CELSIUS, AND IT WAS UNABLE TO PERFORM ENERGIZATION. THE ISSUE WAS NOT RESOLVED BY REPLACING THE CABLE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED COMPROMISED RING 1, 2, AND 3 ELECTRODE SEALS. VISUAL EXAMINATION REVEALED DRIED BODY FLUID IS PRESENT ON THE SHAFT. THERE IS DRIED SALINE ON THE HANDLE AND TIP. THE SEALS OF ALL RINGS (R1, R2, R3) ARE COMPROMISED. ELECTRICAL CONTINUITY CHECKS REVEALED NO ELECTRICAL OPENS OR SHORTS AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX WHEN THE DEVICE WAS IN THE STRAIGHT (NEUTRAL POSITION). HOWEVER, R3 WAS FOUND OPEN IN BOTH CURVE POSITIONS. THE THERMOCOUPLE MEASUREMENT WAS WITHIN SPECIFICATION HOWEVER IS HIGHER THAN WHAT IS TYPICALLY SEEN ON THE BENCH. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH LOCK AND UNLOCK POSITIONS. NO ABNORMAL RESISTANCE WAS FELT WHEN ACT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8207925 ↗
• MalfunctionDec 11, 2018Temperature Problem; Temperature Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 06-DEC-2018. IT WAS REPORTED THAT TEMPERATURE ISSUES OCCURRED. DURING AN ABLATION PROCEDURE WITH A INTELLATIP MIFI OPEN-IRRIGATED CATHETER, ABLATION WAS PERFORMED WITHOUT ISSUE, BUT SUDDENLY THE TEMPERATURE SHOWN WAS ABOVE NUMERICAL VALUE OF 50 CELSIUS TO 60 CELSIUS. THE CABLE WAS REPLACED, BUT ISSUE DID NOT IMPROVE. THE CATHETER WAS REPLACED WITH ANOTHER MIFI OI, THERE WAS NO PROBLEM OBSERVED OF THE DISPLAYED TEMPERATURE, AND ABLATION WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, ANALYSIS REVEALED FLUID INGRESS UNDER ALL RING 2 AND 3 SEALS AND BOTH ELECTRODES. VISUAL INSPECTION SHOWS DRIED BODY FLUID FOUND UNDER BOTH SEALS OF RINGS 2 AND 3, AND UNDER RING 2 AND 3 ELECTRODES. DRIED BODY FLUID ALSO FOUND ON THE HANDLE, MAIN BODY TUBING AND ON THE DISTAL END. DRIED SALINE FOUND ON THE DISTAL END AND INSIDE THE IRRIGATION PORTS. ELECTRICAL CONTINUITY CHECKS REVEALED NO ELECTRICAL OPENS OR SHORTS, AS CHECKED MANUALLY USING A MULTI-METER AND BREAKOUT BOX. ALL ELECTRODES, SENSOR AND THERMOCOUPLE RESISTANCES MEASURED IN SPEC AND WERE TYPICAL. THE STEERING KNOB AND THE TENSION CONTROL KNOB FUNCTIONED PROPERLY ON BOTH

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152169 ↗
• InjuryNov 14, 2018Data Problem; Data Problem

  SAME CASE AS 2134265-2018-62779. IT WAS REPORTED A PERICARDIAL EFFUSION AND CARDIAC ARREST OCCURRED. AN INTELLATIP MIFI OI ABLATION CATHETER AND AN INTELLAMAP ORION MAPPING CATHETER WERE SELECTED FOR USE DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION. IT WAS REPORTED BLOOD PRESSURE SLIGHTLY DECREASED; AN ECHO EXAMINATION WAS PERFORMED AND PERICARDIAL FLUID HAD ACCUMULATED. WHILE PERFORMING A PERICARDIAL PUNCTURE TO REMOVE THE FLUID, CARDIAC ARREST OCCURRED AND PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS PERFORMED. CARDIAC ARREST LASTED APPROXIMATELY 7 MINUTES. THORACOTOMY WAS ALSO PERFORMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S HEART WAS BEATING AND PCPS WAS REMOVED FROM THE PATIENT; THE PATIENT WAS AWAKENING AND NO SUBSEQUENT COMPLICATIONS WERE OBSERVED. THE PROCEDURE HAD NOT BEEN COMPLETED. IT HAD ALSO BEEN NOTED THAT THE TRACKING LOCATION OF THE ABLATION CATHETER WAS INCORRECT ON THE RHYTHMIA SCREEN. HOWEVER, IT WAS REPORTED THE EVENT WAS NOT A DEVICE ISSUE AND THE PHYSICIAN DID NOT BELIEVE THE EFFUSION WAS DUE TO THE CATHETERS. BLOOD LEAKED FROM THE LEFT VENTRICLE; HOWEVER, NEITHER CATHETER HAD BEEN APPROACHED TO THE LE

  Patient problems: Cardiac Arrest; Pericardial Effusion

  MAUDE report 8069562 ↗
• InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME PROCEDURE AS 2134265-2018-60934. IT WAS REPORTED CARDIAC TAMPONADE OCCURRED. AN INTELLAMAP ORION MAPPING CATHETER AND INTELLATIP MIFI OI ABLATION CATHETER WERE SELECTED FOR USE DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE. AFTER ISOLATION OF BOTH PULMONARY VEINS, ATRIAL TACHYCARDIA OF THE RIGHT ATRIUM OCCURRED AND MAPPING WAS COMPLETED. WHEN ABLATION WAS STARTED, BLOOD PRESSURE DECREASED DUE TO CARDIAC TAMPONADE. THREE HUNDRED CC OF BLOOD WERE DRAINED. AFTER THE BLEEDING WAS SUCCESSFULLY STOPPED, ABLATION WAS COMPLETED SUCCESSFULLY WITHOUT ISSUE. IT WAS NOT DETERMINED WHICH CATHETER THE EVENT WAS RELATED TO; THE PHYSICIAN BELIEVED THE TAMPONADE WAS DUE TO LEFT ATRIAL DAMAGE DURING ABLATION OR DURING BROCKENBROUGH. THERE HAD BEEN NO RESISTANCE WHILE MANEUVERING THE CATHETER AND THERE WERE NO DEVICE ISSUES DURING THE PROCEDURE. THE PATIENT WAS STABLE WITH A GOOD OUTCOME.

  Patient problems: Cardiac Tamponade

  MAUDE report 7882384 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS 2134265-2018-60619. IT WAS REPORTED A PERFORATION AND PERICARDIAL EFFUSION OCCURRED. AN INTELLAMAP ORION MAPPING CATHETER AND AN INTELLATIP MIFI OI ABLATION CATHETER WERE SELECTED FOR USE DURING A PAROXYSMAL ATRIAL FIBRILLATION ABLATION PROCEDURE. IT WAS PLANNED TO PERFORM RIGHT PULMONARY VEIN (RPV) ISOLATION FROM LEFT PULMONARY VEIN (LPV) ISOLATION. WHEN THE TRANSITION TO RPV ISOLATION WAS PERFORMED FOLLOWING LPV ISOLATION, THE A PRESSURE DECREASED. ECHOCARDIOGRAPHY CONFIRMED PERICARDIAL EFFUSION AND A PERICARDIAL DRAINAGE WAS PERFORMED. RED BLOOD CELL (RBC) AND FRESH FROZEN PLASMA (FFP) TRANSFUSIONS WERE PERFORMED, BUT DID NOT STOP THE BLEEDING; THEREFORE, SURGICAL INTERVENTION TOOK PLACE. A HOLE WAS FOUND IN THE LEFT SUPERIOR PULMONARY VEIN (LSPV) ANTE. THE PATIENT WAS GETTING BETTER AND RECOVERING. THERE HAD BEEN NO DEVICE ISSUES DURING THE PROCEDURE. THE PERFORATION AND EFFUSION WERE "LIKELY" DUE TO EXCESSIVE ABLATION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 7841461 ↗
• MalfunctionOct 26, 2017Contamination; Contamination

  IT WAS REPORTED THE CATHETER WAS CONTAMINATED WHILE OPENING THE PACKAGE. PRIOR TO AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION, THE MANUFACTURER REPRESENTATIVE WAS OPENING AN INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER. THE PACKAGING RIPPED IN HIS HAND AND HE BRUSHED THE HANDLE OF THE CATHETER. THE DEVICE WAS NOT USED; A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6980464 ↗
• MalfunctionAug 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 17 AUGUST 2017. IT WAS REPORTED THAT THERE WAS ELECTROGRAM (EGM) NOISE AND LOSS OF POTENTIAL OCCURRED. DURING USE OF THE INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER NO ISSUES WERE NOTED WITH CATHETER ELECTRODE 1-2 OR POTENTIAL BEFORE ABLATION WAS STARTED. WHEN STARTING TO DELIVER CURRENT NOISE APPEARED ON ELECTRODE 1-2 AND NO POTENTIAL WAS OBSERVED. CATHETER REPLACEMENT WAS SUGGESTED, BUT POTENTIAL WAS CONFIRMED WHEN CURRENT DELIVERY WAS HALTED. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER; RETURNED DEVICE ANALYSIS REVEALED PEELING AND CUT INSULATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6834424 ↗
• MalfunctionAug 23, 2017Kinked; Device Operates Differently Than Expected; Kinked; Device Operates Differently Than Expected

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14AUG2017. IT WAS REPORTED THAT NOISE OCCURRED DURING ABLATION AND THE TIP OF THE CATHETER WAS KINKED. DURING AN ABLATION PROCEDURE WITH AN INTELLATIP MIFI OI ABLATION CATHETER, SEVERE NOISE APPEARED ON THE POTENTIAL 1-2 OF THE CATHETER AND ALL THE POTENTIAL WAS UNABLE TO BE SEEN. MOREOVER, THE TIP OF THE ABLATION CATHETER GOT STRANGELY BENT AND IT BECAME DIFFICULT TO CAUTERIZE FURTHER. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE WITHOUT ISSUE. NO PATIENT COMPLICATIONS OCCURRED AND THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED A COMPROMISED SEAL AT RING #1, RESULTING IN AN OPENING INTO THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6813356 ↗

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