ARROW IPN001112Recalls & reported problems

Summary

The FDA's MAUDE database contains 394 adverse event reports that list this exact device (DI 30801902084966), received between Jul 6, 2018 and Jun 13, 2024 — classified as 2 injuries, 392 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (59 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 394 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 13, 2024Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED " PUMP SHUT OFF GOING ON BATTERY". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY, THE PUMP WAS SWITCHED OUT WITH NO HARM TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19528585 ↗
• MalfunctionJun 10, 2024Battery Problem; Battery Problem

  IT WAS REPORTED "PUMP STOPPED PUMPING WHEN UNPLUGGED FROM THE WALL OUTLET. DID NOT SWITCH TO BATTERY". TO CONTINUE THERAPY, THE PUMP CONSOLE WAS SWITCHED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19499790 ↗
• MalfunctionJun 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "PUMP THAT IS DOWN WITH A HELIUM LEAK". THIS ISSUE WAS NOTED PRIOR TO USE. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19472096 ↗
• MalfunctionJun 4, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT "PUMP SWITCHING TO AP TRIGGER WITH BOVI. PRIOR TO THE TRIGGER SWITCH, ECG AND AP SIGNAL GOOD, AFTER TRIGGER SWITCH, ARTIFACT NOTED ON AP WAVEFORM AND ERRATIC TRIGGERING. MINIMAL NOISE ARTIFACT NOTED WHEN PUMP IS IN STANDBY. PUMP PUMPING 1:1 ALTHOUGH 1:2 RATIO SELECTED. NO OTHER DEVICES PLUGGED INTO POWER OUTLET, NO SLAVED SIGNALS. PATIENT IN UNIT, CURRENTLY WORKING 'OK' IN 1:2, LESS ARTIFACT THAN IN 1:1". NO PATIENT HARM ON INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461707 ↗
• MalfunctionJun 4, 2024Product Quality Problem; Product Quality Problem

  IT WAS REPORTED "FOUND NO DISPLAY.FOUND BURNT DVI ADAPTER. REPLACE DVI ADAPTER AND BOTH DISPLAY CABLES.INSTALL 1ST AND 2ND BATTERY. PUMP WAS ON PATIENT WHEN NURSE REPORTED BURNING SMELL.PUMP WAS SWAPPED AND NO HARM TO PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 19458171 ↗
• MalfunctionMay 24, 2024Battery Problem; Battery Problem

  IT WAS REPORTED " BATTERY ISSUE". NO PATIENT HARM OR INJURY REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397281 ↗
• MalfunctionMay 22, 2024Device Alarm System; Device Alarm System

  REPORTED AS "REPEATED HELIUM LEAK ALARM". NO REPORT OF PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED. THERAPY WAS DISCONTINUED. THE PATIENT EXPIRED TWO HOURS AFTER THE PUMP WAS DISCONNECTED. HOWEVER, THE PATIENT'S DEATH IS NOT DIRECTLY ATTRIBUTED TO THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 19375124 ↗
• MalfunctionMay 22, 2024Device Alarm System; Device Alarm System

  THE MEDWATCH REPORT STATES, "PATIENT'S (INTRA-AORTIC BALLOON PUMP) BEGAN ALARMING FOR HIGH PRESSURE ALARMS (AROUND THREE SEPARATE INSTANCES OVER THE COURSE OF AN HOUR) CAUSING THE PUMP TO SHUT OFF AND NEED TO BE MANUALLY RESTARTED. THE PATIENT WAS REPOSITIONED TO BE AS FLAT AS POSSIBLE EACH TIME AND THE LINE WAS INSPECTED TO ENSURE THERE WAS NOT KINKING OR BENDING PRESENT. THE (INTRA-AORTIC BALLOON PUMP) CONSOLE THEN ALARMED "SYSTEM ERROR 3, PUMP/VALVE CONTROLLER ERROR" AND SHUT OFF AGAIN. THE LINE AND PATIENT WERE AGAIN INSPECTED WITH NO CHANGES FOUND AND THE PUMP WAS RESTARTED AS PER THE INSTRUCTIONS ON THE CONSOLE WINDOW. THE ALARM HAPPENED TWO MORE TIMES WITH THE PUMP BEING RESTARTED BY STAFF BEFORE THE ENGINEER ARRIVED AND HAD TO SWITCH OUT THE CONSOLE. THE EFFECTED CONSOLE WAS TAKEN AWAY BY THE (INTRA-AORTIC BALLOON PUMP) ENGINEER." AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 19374720 ↗
• MalfunctionMay 22, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED " PUMP SHUT OFF DURING USE 3 TIMES. USER HAD A TOGGLE POWER SWITCH TO RESTART. ALSO OBSERVED TRIGGERING ISSUES. PUMP WAS SWAPPED AND NO HARM TO PATIENT."

  Patient problems: Insufficient Information

  MAUDE report 19372373 ↗
• MalfunctionMay 20, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED VIA MEDWATCH "IABP SCREEN MALFUNCTIONED AND WOULD NOT DISPLAY DATA. IABP WAS STILL INFLATING BALLOON AND ATTEMPTING TO ASSIST PATIENT, BUT SCREEN REMAINED BLACK. NURSING STAFF WAS UNABLE TO ADJUST SETTINGS OR LOOK AT IABP FUNCTION. IABP NEEDED TO BE EXCHANGED". AS IT WAS REPORTED, THE IABP CONSOLE WAS SWITCHED OUT IN ORDER TO CONTINUE THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 19354319 ↗
• InjuryMay 20, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED VIA MEDWATCH " THE IABP WAS ALARMING FOR HELIUM LOSS DETECTED. THE PATIENT WAS REDIRECTED AND REPOSITIONED IN BED WHEN THE BEDSIDE RN NOTIED BLOOD IN THE HELIUM LINE. THE IABP WAS IMMEDIATELY TURNED OFF AND THE LINE WAS CLAMPED. CARDIOLOGY BLUE WAS NOTIFIED AND CAME STRAIGHT TO BEDSIDE. THE PATIENT INITIALLY DENIED ANY CHEST PAIN OR SHORTNESS OF BREATH, AND VITAL SIGNS WERE STABLE. CARDIAC AND VASCULAR SURGERY WERE ALSO CALLED TO BEDSIDE AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM DUE TO IABP RUPTURE".

  Patient problems: Insufficient Information

  MAUDE report 19353745 ↗
• MalfunctionMay 15, 2024Power Problem; Power Problem

  IT WAS REPORTED THAT: "THE PUMP WAS WORKING "FINE" ALL THROUGH THE LAST 2 DAYS AND DURING THE OHS CASE IN THE OR. THEY UNPLUGGED THE PUMP FROM AC POWER TO TRANSPORT TO THE UNIT. THE PUMP ALARMED FOR RUNNING ON BATTERY SHORTLY AFTER THAT. THEN ABOUT 5 MINUTES LATER THE PUMP ALARMED FOR 20 MINUTES OF BATTERY LEFT. THEN ALMOST IMMEDIATELY AFTER THAT IT ALARMED FOR 10 MINUTES LEFT AND IMMEDIATELY AFTER THAT AGAIN FOR 5 MINUTES LEFT. THEN THE PUMP POWERED DOWN ALMOST IMMEDIATELY AFTER THE 5 MINUTES ALERT. THEY QUICKLY SWITCHED TO A SECOND PUMP AND WERE ABLE TO TRANSPORT TO THE UNIT WITHOUT FURTHER ISSUES. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321138 ↗
• MalfunctionMay 15, 2024Defective Device; Defective Device

  IT WAS REPORTED " IABP NOT TRIGGERING PROPERLY IN AUTO PILOT AND WOULD NOT TRGGER PROPERLY IN OPERATOR MODE IN 1:1". ADDITIONAL INFORMATION STATES THAT THE PATIENT WAS NOT HARMED. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 19320926 ↗
• MalfunctionMay 15, 2024Defective Device; Defective Device

  IT WAS REPORTED "IABP NOT TRIGGERING PROPERLY IN AUTO PILOT AND WOULD NOT TRIGGER PROPERLY IN OPERATOR MODE IN 1:1". ADDITIONAL INFORMATION STATES THAT THE PATIENT WAS NOT HARMED.

  Patient problems: Insufficient Information

  MAUDE report 19320831 ↗
• MalfunctionMay 15, 2024Battery Problem; Battery Problem

  IT WAS REPORTED " [CONSOLE] IN SICU THAT HAD BATTERY ISSUES". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19320621 ↗
• MalfunctionMay 10, 2024Defective Device; Defective Device

  IT WAS REPORTED " INTERMITTENT SIGNAL ISSUES ON THE AP WAVEFORM CAUSING TRIGGERING ISSUES". TO CONTINUE/COMPLETE THEAPY THE PUMP WAS RAN IN OPERATOR MODE WITH MULTIPLE TRIGGER CHANGES. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285825 ↗
• MalfunctionMay 8, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "CONTINUOUS ALARM SOUND WITHOUT ANY ALARM HEADER". NO PATIENT INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 19271698 ↗
• MalfunctionMay 7, 2024Power Problem; Power Problem

  IT WAS REPORTED VIA MEDWATCH " WITHIN 14 MINUTES INTRAAORTIC BALLOON PUMP WENT FROM FULLY CHARGED TO 20 MINUTES OF POWER REMAINING. PUMP WAS PLUGGED INTO HELICOPTER. ON ARRIVAL TO WEST PAD, PUMP STATED FULLY CHARGED WE UNLOADED PATIENT (MAYBE 10 MINUTES) IABP SHUT OFF. PUMP WAS RESTARTED AND SHUT OFF AGAIN. IABP WAS PLUGGED INTO WALL OUTLET ON HELIPAD CCU WAS CALLED TO ADVISE THEM OF THIS ISSUE, THEY STATED IT IS A COMMON PROBLEM. IABP SHOWS 80% POWER, CREW THEN GETS ON ELEVATOR AND IABP SHUT OFF AGAIN. WE MADE IT TO THE ROOM AND PLUGGED IT IN. ADDITIONAL INFORMATION STATES THAT THERE WAS NO CONSEQUENECES TO THE PATIENT. HOWEVER, THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19260955 ↗
• MalfunctionMay 1, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED " SCREEN BLANKED OUT AND DID NOT COME BACK". TO CONTINUE THERAPY, THE CONSOLE WAS SWAPPED OUT. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226317 ↗
• MalfunctionMay 1, 2024Defective Device; Defective Device

  IT WAS REPORTED "WHILE IN OPERATING ROOM, ONCE SURGEONS STARTED TO USE BOVI, LOTS OF ARTERIAL PRESSURE INTERFERENCE DESPITE BEING IN AP TRIGGER ON THE IABP." ADDITIONAL INFORMATION REPORTS "HAD PERFUSION USE ANOTHER IABP, IT WORKED BETTER, BUT PERFUSION NOTED SIMILAR RESPONSE DURING USE OF BOVI WHEN IN AP TRIGGER. TAGGED OTHER PUMP, PERFUSION HAS IT IN THEIR PUMP ROOM." NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226117 ↗
• MalfunctionMay 1, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "LARGE HELIUM LEAK AND PURGE FAILURE ALARMS WHILE ON PATIENT." THE IABP WAS EXCHANGED. NO PATIENT HARM OR INJURY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR# 3010532612-2024-00342.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226083 ↗
• MalfunctionMay 1, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED " LARGE HELIUM LEAK AND PURGE FAILURE ALARMS". TO CONTINUE THERAPY THE PUMP CONSOLE WAS EXCHANGED AND THE ISSUE RESOLVED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR# 3010532612-2024-00289.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19226082 ↗
• MalfunctionMay 1, 2024Failure to Run on Battery; Failure to Run on Battery

  IT WAS REPORTED THAT " THE IABP DID NOT HOLD AN ELECTRICAL CHARGE DURING TRANSFER OF THE PATIENT." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". THE CUSTOMER IS UNABLE TO PROVIDE FURTHER DETAIL AROUND THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 19226076 ↗
• MalfunctionApr 30, 2024Defective Device; Defective Device

  IT WAS REPORTED "PUMP IS BEING USED IN OPERATING ROOM IN AP TRIGGER DUE TO BOVIE USE. ARTERIAL PRESSURE HAS ARTIFACT AND IS BEING PICKED UP AT SIGNIFICANTLY HIGHER RATE THAT ACTUAL HEART RATE AND CREATING EXCESSIVE TRIGGERING. VIDEO OF ISSUE WAS SENT TO MY CELL PHONE." THE PUMP WAS NOT REPLACED. NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN" AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 19216470 ↗
• MalfunctionApr 29, 2024Defective Device; Defective Device

  IT WA REPORTED " HIGHLY PIXILATED AP WAVEFORM, INACCURATE TRIGGERING DURING OR CASE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Insufficient Information

  MAUDE report 19202582 ↗