ARROW IPN917286Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10801902172072), received between Aug 1, 2022 and Feb 21, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Power Problem” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT, "THE DISPLAY OF AC3(190934F) APPEARS ABNORMAL SIGNALS DURING PUMPING ON PATIENT. FIRST, THE MONITOR'S ECG AND AP SIGNALS DISAPPEAR (BECOME NOISY AND FLAT) AND HR SHOWS 250 BPM BUT FROM THE SOUND OF PUMPING, THE SYSTEM SEEMS FUNCTIONING NORMALLY. THEN, THE BATTERY AND HELIUM INDICATORS APPEAR "NOT OK" SIGN BRIEFLY. THE ENGINEER HAS CHECKED THE CABLE OF ECG AND AP AND FOUND NOTHING WRONG. THE USER ALSO CONFIRMED THE AC3 HAS BEEN CONNECTED TO MAIN AC POWER SOURCE WHEN IT NOT USED ON PATIENT. NO FURTHER ACTION WAS TAKEN AS THE AC3 IS STILL BEING USED ON THE PATIENT AND THE MACHINE IS CURRENTLY FUNCTIONING NORMALLY. FURTHER INSPECTIONS WILL BE PERFORMED AFTER THE MACHINE IS OFF FROM THE PATIENT". PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16411018 ↗
• MalfunctionFeb 1, 2023Battery Problem; Battery Problem

  THE REPORT STATES THAT THE "[ARROW AC3] IABP SWITCH ITSELF OFF, WHILE IN USE, APPROXIMATELY 30 SECONDS AFTER THE INITIAL 20 MINUTE WARNING. HISTORY OF THIS PUMP LAST SERVICED IN DECEMBER 2021 AND BATTERY REPLACED AT THIS TIME. SERVICE NOW DUE." AS A RESULT, THE PUMP WAS SWAPPED OUT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. FURTHER INFORMATION STATES "THE PATIENT HAD THE CATHETER INSERTED ON THE 28TH DEC AS SHE WAS CRITICALLY ILL AS SHE WAS PRESENTING WITH AN ACUTE MYOCARDIAL INFARCTION. SHE HAD NO ADVERSE EVENT BECAUSE OF THE BATTERY FAILURE AND HAS RECOVERED FROM HER CRITICAL CONDITION".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277839 ↗
• MalfunctionNov 10, 2022Output Problem; Output Problem

  IT WAS REPORTED THAT "THE PATIENT WAS PREPARED IN THE OPERATING ROOM ON (B)(6) 2022 FOR CORONARY ARTERY BYPASS GRAFTING, LEFT VENTRICULAR THROMBECTOMY, VENTRICULAR WALL ANEURYSM RESECTION AND SUTURING UNDER GENERAL ANESTHESIA AND HYPOTHERMIC EXTRACORPOREAL CIRCULATION. IABP WAS USED TO GIVE CARDIAC ASSIST, THE PRODUCT SHOWED SEVERE ECG INTERFERENCE AND COULD NOT MONITOR ECG. THE PATIENT WAS NOT HARMED BY THE REPLACEMENT OF THE IABP". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771736 ↗
• MalfunctionOct 18, 2022Power Problem; Power Problem

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMAL AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT. ASSOCIATED MDRS; 3010532612-2022-00413, 3010532612-2022-00429, 3010532612-2022-00416, 3010532612-2022-00419, AND 3010532612-2022-00417.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620799 ↗
• MalfunctionOct 17, 2022Power Problem; Power Problem

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMAL AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT. ASSOCIATED MDRS; 3010532612-2022-00413, 3010532612-2022-00429, 3010532612-2022-00416, 3010532612-2022-00419, AND 3010532612-2022-00418.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620768 ↗
• MalfunctionOct 17, 2022Power Problem; Power Problem

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMAL AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT. ASSOCIATED MDRS: 3010532612-2022-00413, 3010532612-2022-00416, AND 3010532612-2022-00419.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620763 ↗
• MalfunctionOct 17, 2022Power Problem; Power Problem

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMAL AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT. ASSOCIATED MDRS; 3010532612-2022-00413, 3010532612-2022-00429, AND 3010532612-2022-00416.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620738 ↗
• MalfunctionOct 17, 2022Power Problem; Power Problem

  THE REPORT STATES THAT "THE IABP SYSTEM RESTARTS AUTOMATICALLY. ORIGIN OF FAILURE UNKNOWN, THE SYSTEM WORKS NORMAL AFTER RESTARTING A FEW TIMES". ADDITIONAL INFORMATION STATES THAT THE EVENT OCCURRED PRIOR TO USE ON PATIENT WITH NO PATIENT INVOLVEMENT. ASSOCIATED MDRS; 3010532612-2022-00413, 3010532612-2022-00429, AND 3010532612-2022-00419.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15620726 ↗
• MalfunctionAug 3, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT: "CMA EDUCATOR AND TM WERE RUNNING AN IABP EDUCATION SESSION IN ICU ON (B)(6) 2022 AT (B)(6). DURING THE SESSION WE NOTED THAT THE CONDENSATE BOTTLE AT THE BACK OF THE PUMP HAD A DISCOLOURED LIQUID IN IT. NOTIFIED STAFF FROM (B)(6)- ASKED TO GET A URINE DIPSTICK TO CHECK IF IT IS BLOOD. UPON DIPSTICK TEST NOTED TO BE POSITIVE FOR BLOOD. STAFF UNSURE WHEN THE PUMP WAS LAST ON A PATIENT AND NATURE OF THE INCIDENT". ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE CUSTOMER. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 15161095 ↗
• MalfunctionAug 1, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PUMP WOULD RESTART AUTOMATICALLY FOR A FEW TIMES AND THEN WORK NORMALLY. THE USER WAS UNABLE TO FIND ROOT CAUSE SINCE THE PUMP WORK NORMALLY NOW. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142012 ↗
• MalfunctionAug 1, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PUMP WOULD RESTART AUTOMATICALLY FOR A FEW TIMES AND THEN WORK NORMALLY. THE USER WAS UNABLE TO FIND ROOT CAUSE SINCE THE PUMP WORK NORMALLY NOW. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141958 ↗
• MalfunctionAug 1, 2022Power Problem; Power Problem

  IT WAS REPORTED THAT THE PUMP WOULD RESTART AUTOMATICALLY FOR A FEW TIMES AND THEN WORK NORMALLY. THE USER WAS UNABLE TO FIND ROOT CAUSE SINCE THE PUMP WORKS NORMALLY NOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15141919 ↗