Cool Point™ IBI-89003Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05415067008985), received between Jul 10, 2018 and Mar 18, 2026 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (8 reports).

1 other recall cover devices cleared under the same FDA submission (P060019); 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.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Pressure Problem

  DURING AN ATRIAL FLUTTER (AFL) AND AVNRT PROCEDURE, PRESSURE ISSUES RESULTED IN THE PROCEDURE BEING CANCELLED. A CONTINUOUS PRESSURE ERROR WAS NOTED. THE TUBING SET WAS REPLACED TWICE, AND THE ADAPTOR WAS TAKEN OFF THE FRONT OF THE DEVICE AND PLUGGED DIRECTLY INTO THE PUMP, BUT THE ISSUE PERSISTED. THE PRESSURE ADAPTER WAS ALSO REPLACED WITH NO RESOLUTION. THE AFL PART OF THE PROCEDURE WAS COMPLETED USING THE NON-ABBOTT PFA SYSTEM (BOSTON SCIENTIFIC PFA SYSTEM), BUT THE PATIENT WILL HAVE TO RETURN TO COMPLETE THE AVNRT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634639 ↗
• MalfunctionDec 11, 2024Pressure Problem; Pressure Problem

  DURING THE ATRIAL TACHYCARDIA PROCEDURE, IRRIGATION FLOW ISSUES RESULTED IN A PROCEDURAL DELAY. IT WAS NOT POSSIBLE TO FLUSH THE ABLATION CATHETER. THE FLOW SEEMED FINE PRIOR TO CONNECTING THE CATHETER, BUT ONCE THE CATHETER WAS CONNECTED IT WAS LIMITED. EXCHANGING THE CATHETER AND TUBING SET DID NOT RESOLVE THE ISSUE. THE COOL POINT PUMP WAS REPLACED WHICH IMPROVED THE FLOW RATE AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904380 ↗
• MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING AN ATRIAL FIBRILLATION ATRIAL FLUTTER PROCEDURE, THE COOL POINT PUMP WAS NOTED TO BE DAMAGE WHICH RESULTED IN CANCELLATION OF THE PROCEDURE. IT WAS NOT POSSIBLE TO SQUEEZE THE TUBING SET ENOUGH TO CORRECTLY PUMP. THE ABLATION CATHETER WAS CHANGED TO A NON-IRRIGATED CATHETER, HOWEVER NO ABLATION OCCURRED SO THE PROCEDURE WAS NOT COMPLETED. IT WAS FOUND A SCREW FROM THE PLASTIC COVER/HINGE MECHANISM HAD DISLODGED AND PREVENTED THE COOL POINT PUMP FROM WORKING PROPERLY. THE SCREW WAS PUT BACK IN PLACE AND THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17025422 ↗
• MalfunctionFeb 9, 2023Pressure Problem; Pressure Problem

  DURING AN AT PROCEDURE, IT WAS NOTED THAT THE PRESSURE ALARM OCCURRED WHEN ATTEMPTING TO FLUSH A NON-ABBOTT DEVICE (BIOSENSE CATHETER) WHICH CAUSED PROCEDURAL DELAYS. THE COOL POINT PUMP WAS RESTARTED, THE PRESSURE ADAPTER CABLE WAS RESEATED, AND THE CATHETER EXCHANGED, BUT THE ISSUE PERSISTED. THE COOL POINT PUMP WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED WITHOUT ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16337185 ↗
• MalfunctionOct 20, 2022Unexpected Shutdown; Unexpected Shutdown

  DURING THE PREMATURE VENTRICULAR CONTRACTIONS PROCEDURE, THE COOL POINT PUMP WOULD UNINTENTIONALLY POWER OFF AND NEEDED TO BE RESTARTED 6-8 TIMES DURING THE PROCEDURE RESULTING IN A DELAY. THE CATHETER WAS EXCHANGED WITH A SAFIRE 4MM DRY TIP ABLATION CATHETER UNTIL ANOTHER COOL POINT PUMP COULD BE USED. THE DRY TIP RF LESIONS WERE REINFORCED WITH THE TACTICATH SE ABLATION CATHETER WITH IRRIGATION USING A SPARE COOL POINT PUMP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639165 ↗
• MalfunctionMay 3, 2022Pressure Problem; Pressure Problem

  DURING A RADIO FREQUENCY ATRIAL FIBRILLATION ABLATION PROCEDURE, WHEN THE CATHETER WAS INSERTED INTO THE LEFT ATRIUM, THE IMPEDANCE AND TEMPERATURE ROSE WHILE ON ABLATION. HIGH FLOW RATE WAS INITIATED ON THE PUMP TO SEE IF CATHETER WAS IRRIGATING CORRECTLY. AT HIGH FLOW RATE IT WAS FOUND THAT NORMAL HIGH FLOW VOLUME WAS NOT BEING DELIVERED TO CATHETER TIP. THE CATHETER WAS THEN REPLACED FOR A NEW ONE. HIGH FLOW RATE WAS TESTED AGAIN ON THE CATHETER AND ISSUE PERSISTED. THE CASE WAS THEN ABORTED DUE TO NOT HAVING A FUNCTIONAL PUMP. THE PATIENT SUSTAINED NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269041 ↗
• MalfunctionJan 26, 2022Pressure Problem; Pressure Problem

  DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, DUE TO A PRESSURE ERROR WITH THE PUMP AND THE TROUBLESHOOTING INVOLVED TO RESOLVE THE ISSUE, A PROLONGED PROCEDURE OCCURRED. INITIALLY A NEW TUBING SET AND PRESSURE ADAPTER CABLE WERE ATTEMPTED, BUT THE ISSUE REMAINED. A PUMP WAS BORROWED FROM A NEARBY ACCOUNT AND THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. FOLLOWING THE COMPLETION THE PROCEDURE, THE ORIGINAL PUMP WAS RECONNECTED AND WAS OBSERVED TO BE FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13358886 ↗
• MalfunctionOct 14, 2021Pressure Problem; Pressure Problem

  DURING A PREMATURE VENTRICULAR CONTRACTION PROCEDURE, A PRESSURE SENSOR ERROR OCCURRED AND THE PUMP STOPPED WORKING. A REPLACEMENT PUMP WAS BORROWED FROM ANOTHER FACILITY WHICH DELAYED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632893 ↗
• MalfunctionOct 14, 2021Output Problem; Output Problem

  DURING AN ATRIAL TACHYCARDIA PROCEDURE, A DELAY OCCURRED. HIGH TEMPERATURE ERRORS WERE NOTED ON THE ABLATION CATHETER WHEN COMING ON ABLATION FOR SEVERAL SECONDS. THE GENERATOR WAS REPLACED, BUT DID NOT RESOLVE THE ISSUE. A NON ABBOTT ABLATION CATHETER WAS USED USED TO CONTINUE THE PROCEDURE WITH NO CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631326 ↗
• MalfunctionOct 6, 2021Overheating of Device; Overheating of Device

  DURING A TYPICAL ATRIAL FLUTTER ABLATION PROCEDURE, A HIGH TEMPERATURE ERROR DISPLAYED WHEN ABLATION WAS DELIVERED AND THE PROCEDURE HAD TO BE CANCELLED DUE TO THE ISSUE NOT BEING ABLE TO BE RESOLVED. DESPITE MULTIPLE TROUBLESHOOTING EFFORTS, THE HIGH TEMPERATURE ERROR WAS UNABLE TO BE CLEARED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583909 ↗
• MalfunctionAug 19, 2021Mechanical Problem; Mechanical Problem

  DURING A SUPRAVENTRICULAR TACHYCARDIA ABLATION PROCEDURE, THE PUMP WHEEL WOULD NOT TURN AND DUE TO HAVING TO BORROW A REPLACEMENT PUMP FROM A DIFFERENT HOSPITAL DURING THE PROCEDURE, A PROLONGED PROCEDURE OCCURRED. THE PROCEDURE WAS ABLE TO BE SUCCESSFULLY COMPLETED WITH THE REPLACEMENT PUMP WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12341699 ↗
• MalfunctionAug 10, 2021Signal Artifact/Noise; Signal Artifact/Noise

  DURING A PROCEDURE, NOISE WAS NOTED ON THE TACTICATH DISTAL CHANNEL WHEN THE PUMP WAS FLOWING AND A DELAY OCCURRED. THERE WAS NO NOISE ON THE PROXIMAL CHANNEL. THE EGM CABLE WAS SWAPPED OUT WITH A SPARE AND THE DISTAL CHANNEL WAS REASSIGNED BUT THE ISSUE PERSISTED. THE GROUNDING PATCH WAS MOVED AND ANOTHER PUMP WAS BORROWED WHICH DID NOT RESOLVE THE NOISE ISSUE. IT WAS DECIDED TO PROCEED AND USE DIFFERENT FILTERS ON THE ABLATOR DISTAL SIGNAL. CHANGING THE TUBING, ABLATION CATHETER, UNPLUGGING THE GENERATOR, PUMP, AND TACTISYS DID NOT RESOLVE THE ISSUE. THE FILTERS AND GAIN WERE CHANGED ON THE RECORDING SYSTEM, THE PIN OF THE ABLATION CATHETER WAS CONNECTED TO DIFFERENT PINS ON THE PINBLOCK AND THE CABLE WAS EXCHANGED WHICH DID NOT RESOLVE THE ISSUE. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. THE POWER CORDS HAVE BEEN PLUGGED INTO DIFFERENT POWER SOURCES TO MITIGATE THE CHANCES OF THIS HAPPENING AGAIN. CASES HAVE BEEN PERFORMED SINCE THIS ISSUE WITH NO NOISE AND THE HOSPITAL CONTINUES TO USE THE PUMP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300033 ↗
• InjuryNov 14, 2019Pressure Problem; Pressure Problem

  RELATED MANUFACTURER REFERENCE: 2184149-2019-00220, 3008452825-2019-00574, 3005334138-2019-00629. DURING A PROCEDURE, THE DIAGNOSTIC CATHETERS AND THEIR RESPECTIVE SIGNALS DISPLAYED AS EXPECTED ON THE ENSITE SYSTEM. WHEN THE ABLATION CATHETER WAS CONNECTED, THE COOL POINT PUMP FUNCTIONED AS EXPECTED AND THE CALIBRATION OF THE CONTACT FORCE MEASUREMENT WAS CONDUCTED SUCCESSFULLY. WHEN THE ABLATION CATHETER WAS INSERTED INTO THE PATIENT, THE DISTAL ELECTRODE AND M3 WERE NOT RECOGNIZED AND WAS DISTORTED ON ENSITE. THE CONNECTIONS WERE CHECKED AND VALIDATED, ENSURING PROPER CONNECTION. THE CATHETER WAS EXCHANGED FOR ANOTHER TACTICATH SE AND THE SAME ISSUE OCCURRED. IT WAS ALSO NOT POSSIBLE TO PERFORM THE CALIBRATION OF THE CONTACT FORCE FOR THE CATHETER. A PRESSURE ERROR WAS ALSO NOTED ON THE COOL POINT PUMP. ANOTHER MAPPING SYSTEM WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THERE WAS APPROXIMATELY A 45 MINUTE DELAY IN THE PROCEDURE WHICH WAS CLINICALLY SIGNIFICANT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9325400 ↗
• InjuryJul 24, 2019Intermittent Energy Output; Intermittent Energy Output

  DURING AN EP PROCEDURE AS ABLATION STARTED AND THE TUBING SET WAS PURGED, THE PUMP INDICATED A SHORT CIRCUIT AS IT WAS TURNING ON AND OFF. WHEN THE PUMP WAS ON IT DISPLAYED A DISPLAY ALARM. DIFFERENT POSITIONS WERE TRIED WITH NO SUCCESS. THE PROCEDURE WAS CANCELLED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823745 ↗
• InjuryJun 11, 2019Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ABLATION PROCEDURE, A DELAY OCCURRED DUE TO ABLATION POWER ISSUE. DURING THE PROCEDURE, ABLATION POWER STAYED BETWEEN 2-4 W DESPITE POWER BEING AT 45 W AND INCREASING FLOW RATE TO 30M WITH NO CHANGE IN EGM WITH ABLATION. FOLLOWING REMOVAL OF THE ABLATION CATHETER, IT WAS DISCOVERED THAT THE STOPCOCK WAS IN THE OFF POSITION TO THE PATIENT. NO WARNING WAS RECEIVED ON THE COOL POINT PUMP THROUGHOUT THE 25 MINUTES OF TROUBLESHOOTING. AFTER THE STOPCOCK ON THE TUBING WAS TURNED TO THE OPEN POSITION TO THE PATIENT, THE CTI LINE WAS RE ABLATED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT, HOWEVER THE PROCEDURE WAS PROLONGED BY APPROXIMATELY 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8686260 ↗
• InjuryOct 19, 2018Pressure Problem; Pressure Problem

  DURING A PROCEDURE A PRESSURE SENSOR ERROR WAS DISPLAYED ON THE PUMP, WHICH COULD NOT BE CLEARED AND ABLATION COULD NOT BE PERFORMED. THE PATIENT WAS ALREADY PREPPED AND HAD CATHETERS IN PLACE WHEN THE PROCEDURE WAS CANCELLED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985728 ↗
• InjuryJul 10, 2018Use of Device Problem; Use of Device Problem

  DURING THE PROCEDURE, AN AIR EMBOLISM OCCURRED. THE SALINE BAG BECAME EMPTY WHILE IN THE LEFT ATRIUM AND WHILE SWITCHING THE BAG, THE OPERATOR INADVERTENTLY ADJUSTED THE VALVE SO AIR WAS FLUSHED INTO THE LEFT ATRIUM.

  Patient problems: Air Embolism

  MAUDE report 7672966 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P060019. One submission often covers many models, so check the product and lot details in each record.

• Z-1032-2012 · Jan 5, 2012 · Terminated
  The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Abl