ARROW IPN917288Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10801902172096), received between Nov 30, 2021 and Jun 11, 2024 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED " THE ALARM "SYSTEM MALFUNCTION" APPEARED IN THE PROCESS OF USE, AND AFTER CHECKING, THE MOTOR COULD NOT BE STARTED, AND THERE WAS A STRANGE SOUND OF THE MOTOR BEING STUCK, SO IT WAS JUDGED THAT THERE WAS A PROBLEM WITH THE MOTOR AND IT COULD NOT BE USED". TO CONTINUE THERAPY, THE PUMP CONSOLE WAS SWITCHED 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 19511088 ↗
• MalfunctionMay 23, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED " THE PATIENT WAS UNDERGOING AORTIC COUNTERPULSATION THERAPY WHEN THE ECG SIGNAL WAS LOST AND THREE ATTEMPTS TO REBOOT THE DEVICE STILL DID NOT DISENGAGE IT. AFTER REPLACING THE ECG LEADWIRE, IT RETURNED TO NORMAL. ADDITIONAL INFORMATION ALSO STATES THAT THE PUMP CONSOLE WAS SWITCHED OUT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383986 ↗
• MalfunctionMay 17, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED " THE PUMP WAS MAKING ABNORMAL NOISES AND ALARMING "BASELINE TOO HIGH" SEVERAL TIMES. ON (B)(6), THE ENGINEER SERVICED THE UNIT AND TESTED IT FOR 1 HOUR, AND THERE WERE 2 ALARMS, ONE FOR "HELIUM LEAK" AND ONE FOR "BASELINE TOO HIGH". THE PATIENTS CURRENT CONDITION IS UNKNOWN. 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 19339884 ↗
• MalfunctionMay 8, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, "POWER-ON DEVICE ALARM, ABNORMAL BATTERY SUPPLY". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19271441 ↗
• MalfunctionApr 5, 2024Battery Problem; Battery Problem

  IT WAS REPORTED "THE POWER SUPPL IS INTERRUPTED DURING USE, UNABLE TO TUN ON THE POWER AND A LONG ALARM SOUNDS". THIS ISSUE DID NOT OCCUR DURING USE ON A PATIENT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052249 ↗
• MalfunctionMar 14, 2024Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE BATTERY EXPERIENCED A POWER LOSS AND CAN NOT BE POWERED ON. AFTER 24 HOURS OF CHARGING THE PUMP WOULD STILL NOT TURN ON. AFTER USING AC POWER THE PUMP WAS ABLE TO BE POWERED ON BUT THEN SWITCHED OFF AUTOMATICALLY AND THE SCREEN WENT BLACK. THIS MALFUNCTION WAS FOUND DURING INCOMING INSPECTION. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903728 ↗
• MalfunctionJan 12, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT DURING INCOMING INSPECTION "THERE WAS A SUSPICIOUS HELIUM LEAK 2, AND UPON RETURNING TO THE INTENSIVE CARE UNIT, THE ALARM OCCURRED FREQUENTLY. NO CREASES WERE OBSERVED ON THE CATHETER DURING EXTERNAL OBSERVATION, AND THE CATHETER WAS ADJUSTED IN POSITION INSIDE THE BODY. THE ELECTRODE POSITION AND HELIUM CAPACITY HAVE ALSO BEEN ADJUSTED, BUT THE ALARM STILL APPEARS". AS A RESULT THE PUMP WAS EXCHANGED FOR ANOTHER PUMP. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18507513 ↗
• MalfunctionSep 12, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "PCS BOARD FAILURE DUE TO HELIUM LOSS 2 ALARM EVEN BE USED WITH SIMULATORS". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731418 ↗
• MalfunctionJul 26, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, "THE INTRA-AORTIC BALLOON PUMP GAS WAS USED TOO QUICKLY, AFFECTING THE NORMAL USE OF THE EQUIPMENT". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". AS PER THE ADDITIONAL INFORMATION, THE PATIENT HAD AN UNDERLYING MEDICAL CONDITION OF CORONARY HEART DISEASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398750 ↗
• MalfunctionJul 25, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT, "DURING THE UNPACKING INSPECTION AND SIMULATION TEST RUN, WHEN USING THE SIMULATOR OR BUILT-IN MODE, IT WAS FOUND THAT THE PLATFORM PERIOD OF THE COUNTERPULSATION REMAINED HIGH AT ABOUT 185, WHILE UNDER THE SAME CONDITIONS, THE PLATFORM PERIOD WAS ABOUT 125 WHEN OTHER MACHINES WERE RUNNING. WHEN USING A SAMPLE BALLOON FOR COUNTERPULSATION, THE MACHINE WILL ALARM FOR HIGH PRESSURE, HELIUM LEAKAGE, ETC., AND STOP THE COUNTERPULSATION. IT IS PRELIMINARILY DETERMINED THAT THIS MACHINE HAS A MALFUNCTION". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388929 ↗
• MalfunctionDec 14, 2022Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE "USER REPORTED THE PUMP AUTOMATICALLY RESTARTED WHILE ON PATIENT. THE PUMP WORKED NORMALLY WHEN THE ENGINEER PERFORMED THE CHECK, WAS UNABLE TO REPLICATE THE ISSUE". ADDITIONAL INFORMATION STATES THAT THE PUMP WAS SWITCHED OUT FOR ANOTHER NON-ARROW PUMP AND THAT NO MEDICAL INTERVENTION WAS REQUIRED. THE "PATIENT IS IN GOOD CONDITION". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980881 ↗
• MalfunctionOct 28, 2022Smoking; Smoking

  IT WAS REPORTED THAT WHILE IN USE ON A PATIENT THE IABP PRINTER HAD DIFFICULTY PRINTING AND THE PAPER THAT DID PRINT OUT HAD BURNT EDGES. A SMALL AMOUNT OF SMOKE WAS OBSERVED AS WELL. THE ISSUE WAS RESOLVED BY REPLACING THE PRINTER WITH A DEMO PRINTER. NO REPORT OF HARM OR INJURY TO THE PATIENT, THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691457 ↗
• MalfunctionMay 4, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A SYSTEM ERROR 3 ALARM OCCURRED DURING USED. AS A RESULT, ANOTHER PUMP WAS USED TO COMPLETE THERAPY. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY, OR DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14280512 ↗
• MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem

  THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE, AN ABNORMAL MOTOR SOUND WAS FOUND WHEN THE EQUIPMENT WAS TURNED ON. A RED LEVEL 1 ALARM DISPLAYED ON THE SCREEN: SYSTEM ERROR 3, WHICH WAS DETECTED AS STEPPING MOTOR FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899719 ↗