ARROW IPN001113Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 30801902091254), received between Aug 29, 2022 and May 16, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2024Defective Device; Defective Device

  IT WAS REPORTED " THE MONITOR HEART RATE WAS 40 - 50, THE IABP HEART RATE WAS 100 - 140, THE AP PRESSURE MONITOR WAS 115/40 (63), AND THE IABP SHOWED 77/38 (58). THE DATA IS NOT SYNCHRONIZED, HEART RATE, AP VALUES ARE TOO DIFFERENT. THIS STATE HAS PERSISTED. MANUALLY CUTTING TO AP TRIGGERS COUNTER PULSATION, WHICH BASICALLY SYNCHRONIZES. HOWEVER, IN AUTO MODE, THE MACHINE WILL SELECT ECG TRIGGER, THE DATA IS NOT SYNCHRONIZED, HEART RATE, AP VALUES ARE TOO DIFFERENT". ADDITIONAL INFORMATION STATES THAT THE PUMP CONSOLE WAS REPLACED TO CONTINUE THERAPY. 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 19336772 ↗
• MalfunctionMay 3, 2024Computer Software Problem; Computer Software Problem

  IT WAS REPORTED "SPLASH SCREEN WHEN USING IABP". TO CONTINUE THERAPY, THE PUMP CONSOLE WAS CHANGED OUT. NO PATIENT HARM OR INJURY REPORTED. THE PATIENET'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19240368 ↗
• MalfunctionApr 8, 2024Delayed Charge Time; Delayed Charge Time

  IT WAS REPORTED " THE UNIT WAS FOUND TO HAVE BEEN CHARGED OVERNIGHT PRIOR TO USE AND WAS LEFT CHARGING". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19065161 ↗
• MalfunctionMar 21, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "AFTER CONNECTING THE PUMP, IT WAS FOUND TO BE MALFUNCTIONING, AND THEN THE PUMP WAS REPLACED". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949829 ↗
• MalfunctionFeb 9, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "DURING THE INSPECTION OF THE IABP, HIGH BASELINE ALARM OCCURRED. THE ALARM OCCURED AGAIN AFTER CHANGING THE BALLOON SIMULATOR. THE CPM BOARD AND MOTOR DRIVER WERE REPLACED, BUT THE ALARM WAS NOT RESOLVED. AFTER THAT, THE PUMP ASSEMBLY WAS REPLACED AND THE ISSUE WAS RESOLVED." NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681575 ↗
• MalfunctionAug 21, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "THE PATIENT WAS ADMITTED TO ICU AFTER CORONARY ARTERY BYPASS SURGERY RESECTION OF VENTRICULAR ANEURYSM, AND IABP WAS USED TO ASSIST CIRCULATION. ON THE MORNING OF (B)(6), 2023, THE IABP REPEATEDLY REPORTED SYSTEM MALFUNCTION 3, AND IMMEDIATELY REPLACED THE PATIENT WITH AN IABP MACHINE FOR TREATMENT. NO HARM WAS CAUSED TO THE PATIENT, AND THE ENGINEER WAS IMMEDIATELY CONTACTED FOR MAINTENANCE AND TESTING". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17585964 ↗
• MalfunctionMay 30, 2023Complete Loss of Power; Complete Loss of Power

  IT WAS REPORTED THAT, "DURING USE, THE MACHINE ALARM SUDDENLY INDICATED THAT 'THE PUMP STOPPED FOR MORE THAN THREE MINUTES', AND AFTER THREE MINUTES THE MACHINE STARTED TO AUTOMATICALLY REBOOT. IMMEDIATELY STOP USING AND CONTACT THE ENGINEER." NO PATIENT HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED STATES "THE PATIENT CONDITION IS FINE. OUR ENGINEER GO TO HOSPITAL, AND DO THE TEST, NO REPEAT FAILURE OCCURRED". IT IS UNCLEAR FROM THE CUSTOMER IF THE PUMP WAS SWAPPED OUT FOR ANOTHER. IF FURTHER INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019679 ↗
• MalfunctionDec 13, 2022Unexpected Shutdown; Unexpected Shutdown

  THE REPORT STATES THAT "USER REPORTED THE PUMP AUTOMATICALLY RESTARTED WHILE ON PATIENT, USER HAD TO PRESS 'START PUMP' AGAIN AFTER SYSTEM RESTARTED. PUMP WORKS NORMALLY WHEN ENGINEER PERFORMED THE CHECK, UNABLE TO REPLICATE THE ISSUE". ADDITIONAL INFORMATION STATES "THE USER CONTINUED TO USE THE SAME PUMP AFTER THE RESTART". THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE PATIENT IS IN "GOOD CONDITION" NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973432 ↗
• MalfunctionNov 10, 2022Intermittent Loss of Power; Intermittent Loss of Power

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMALLY AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15774930 ↗
• MalfunctionAug 29, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT "THE AC3 DISPLAYS AN ERROR 3 ALARM WHEN THE USER TURNS ON THE AC3 POWER SWITCH. AS A RESULT, THE PUMP ASSEMBLY WAS REPLACED AND THE PUMP WORKED NORMALLY". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310482 ↗