ARROW IPN000252Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00801902034724), received between Jul 16, 2018 and Jul 24, 2025 — classified as 8 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (18 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER A FEW COUNTERPULSATIONS, THE MACHINE STOPPED AND DISPLAYED AN ERROR INDICATING A POSSIBLE KINKED CATHETER OR A BALLOON THAT WAS NOT INFLATING CORRECTLY. AFTER VERIFYING THAT ALL CONNECTIONS WERE INDEED CORRECT AND THAT THE BALLOON WAS PROPERLY POSITIONED UNDER FLUOROSCOPY, I RESTARTED THE COUNTERPULSATION, BUT THE SAME ERROR WAS REPORTED AGAIN". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22589131 ↗
• MalfunctionJul 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "SUSPECTED ABRASION, AP CAL KEY DATA NOT READ". ADDITIONAL INFORMATION STATES "LEAK TEST COMPLETED AND IAB FAILED. IAB REMOVED WITHOUT DIFFICULTY". THE CUSTOMER REPORTS THAT TO CONTINUE THERAPY ANOTHER IAB CATHETER WAS INSERTED. 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 22396743 ↗
• MalfunctionMay 27, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT "THE FIRST IAB WAS REMOVED DUE TO A 'HELIUM ALARM'". A NEW DEVICE WAS INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091114 ↗
• MalfunctionApr 25, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON WAS CAUSING HIGH PRESSURE ALARMS POTENTIALLY BECAUSE IT WAS NOT UNRAVELING ALL THE WAY. BALLOON WAS REMOVED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. 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 21908986 ↗
• MalfunctionApr 15, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "FAILURE TO DETECT ARTERIAL PRESSURE; IAB THERAPY PERFORMED ONLY VIA ECG WITH SYNC ON R-WAVE". ADDITIONAL INFORMATION STATES THAT THE IAB CATHTER WAS REMOVED AND NOT REPLACED. THE PATIENT WAS MEDICALLY MANAGED WITH INOROPES. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21840345 ↗
• MalfunctionApr 9, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "POTENTIAL IAB ABRASION- PERSISTENT HELIUM LOSS 2 ALARMS UNRESOLVED". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. 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 21808265 ↗
• MalfunctionApr 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "DELAYED UNWRAPPING". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE IAB CATHETER WAS LEFT IN PLACE AND CONTINUED TO SUPPORT THE PATIENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807199 ↗
• MalfunctionFeb 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED "PERSISTENT HELIUM LOSS 2 ALARMS". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 21469485 ↗
• MalfunctionFeb 10, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "KEPT ALARMING THAT THERE WAS A HELIUM LEAK". THE CUSTOMER HAS BEEN UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION SUR ROUNDING THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21343542 ↗
• MalfunctionDec 26, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED " THE CATHETER DID NOT ZERO BEFORE INSERTION, WHICH IS NOT ALWAYS UNUSUAL. WE SWAPPED THE CONSOLES WHICH DIDN'T MAKE ANY DIFFERENCE TO BEING ABLE TO USE IT. AFTER INSERTION INTO THE PATIENT AND ACTIVATING THE PUMP THE BALLOON CATHETER REGISTERED AN ERROR HELIUM LEAK ON THE CONSOLE. IT WAS REMOVED IMMEDIATELY AND ANOTHER CATHETER WAS OPENED". ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 21020317 ↗
• MalfunctionNov 19, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "IAB ABRASION/RUPTURE". ADDITIONAL INFORMATION STATES THAT " BLOOD IN GAS LINE. PATIENT IS VERY PUMP DEPENDENT. IAB REMOVED AND REPLACED, WIRE PLACED SAME ASSCESS SITE. NO ISSUES WITH REMOVAL OR REINSERTION. PATIENT STABLE WITH NO ALARMS OR ISSUES WITH NEW IAB." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 20724809 ↗
• MalfunctionNov 18, 2024Break; Break

  IT WAS REPORTED "IAB RUPTURE/ABRASION". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS NOT REPLACED DUE TO " PATIENT REMAINED STABLE WITHOUT THERAPY". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20712379 ↗
• MalfunctionOct 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "HELIUM LOSS ALARMS, NOTED LEAK SOUND AT CATHETER BIFURCATION. SECOND CATHETER INSERTED (40CC). POSSIBLE HELIUM LOSS 3 ALARM RESOLVED". ADDITIONAL INFORMATION STATES THAT A SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 20429058 ↗
• MalfunctionSep 5, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "FREQUENT POSSIBLE HELIUM LOSS ALARMS WHEN STARTING THERAPY AFTER INSERTION IN THE CATH LAB". TO CONTINUE THERAPY, ANOTHER IAB CATHETER WAS INSERTED OF A DIFFERENT BRAND AND WORKED FINE. 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 20148647 ↗
• InjuryAug 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURE". THE REPORT STATES, "PUMP ALARMED HELIUM LOSS, NURSE NOTED BLOOD IN THE DRIVELINE. WITHIN 25 MINUTES RESIDENT REMOVED IAB IN THE ICU. WHEN THE RESIDENT WAS REMOVING THE IAB HE MET RESISTANCE AND CONTINUED TO PULL THE IAB. THE IAB WAS STUCK IN SHEATH BOTH REMOVED TOGETHER FORCEFULLY. HELD PRESSURE ON SITE FOR 45 MIN. NOTED A COLD LOWER EXTREMITY. BROUGHT PATIENT TO OR FOR VASCULAR SURGERY WHO PERFORMED A THROMBECTOMY. THROMBECTOMY SUCCESSFUL BUT PATIENT STILL REMAINS IN INTENSIVE CARE. THE IAB WAS PLACED ON THE JULY 18 AND RUPTURED OCCURRED JULY 19. A LOT OF CALCIFICATION NOTED BY CT SURGEON IN SURGERY NOTES. IAB FUNCTIONED THROUGH THE NIGHT WITH NO ALARMS WHEN IT WAS PLACED ON JULY 18". SEE ASSOCIATED MDR # 3010532612-2024-00706.

  Patient problems: Laceration(s)

  MAUDE report 20078561 ↗
• MalfunctionAug 27, 2024Device Alarm System; Device Alarm System

  REPORTED AS "IAB RUPTURE". THE REPORT STATES, "PUMP ALARMED HELIUM LOSS, NURSE NOTED BLOOD IN THE DRIVELINE. WITHIN 25 MINUTES RESIDENT REMOVED IAB IN THE ICU. WHEN THE RESIDENT WAS REMOVING THE IAB HE MET RESISTANCE AND CONTINUED TO PULL THE IAB. THE IAB WAS STUCK IN SHEATH BOTH REMOVED TOGETHER FORCEFULLY. HELD PRESSURE ON SITE FOR 45 MIN. NOTED A COLD LOWER EXTREMITY. BROUGHT PATIENT TO OR FOR VASCULAR SURGERY WHO PERFORMED A THROMBECTOMY. THROMBECTOMY SUCCESSFUL BUT PATIENT STILL REMAINS IN INTENSIVE CARE. THE IAB WAS PLACED ON THE JULY 18 AND RUPTURED OCCURRED JULY 19. A LOT OF CALCIFICATION NOTED BY CT SURGEON IN SURGERY NOTES. IAB FUNCTIONED THROUGH THE NIGHT WITH NO ALARMS WHEN IT WAS PLACED ON JULY 18". SEE ASSOCIATED MDR # 3010532612-2024-00707

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20078383 ↗
• MalfunctionAug 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED VIA MEDWATCH "THE CARDIOLOGIST INSERTED THE BALLOON PUMP, THE BALLOON WOULD NOT INFLATE ALL THE WAY. NEEDED TO USE A DIFFERENT BALLOON WITHOUT ISSUE". NO ADDITIONAL INFORMATION SURROUNDING THIS EVENT IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 20035825 ↗
• MalfunctionJul 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER INSERTION, "BALLOON DID NOT FULLY INFLATE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19750619 ↗
• MalfunctionJul 15, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "RECEIVING A POSSIBLE HELIUM LOSS 3 ALARM. BALLOON DOES NOT APPEAR TO BE FULLY UNWRAPPED". A SECOND CATHETER WAS INSERTED IN THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744005 ↗
• MalfunctionJun 7, 2024Connection Problem; Connection Problem

  IT WAS REPORTED " FOS UNABLE TO CONNECT" NO PATIENT INJURY OR CONSEQUENCE REPORTED. ADDITIONAL INFORMATION STATES THAT ANOTHER IAB WAS INSERTED TO CONDINTUE THERAPY. THE PATIENT S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486609 ↗
• MalfunctionApr 8, 2024Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS "IAB RUPTURE". THE REPORT STATES THAT "CARDIOLOGY FELLOW WAS REPOSITIONING THE IAB WHEN BLOOD WAS NOTED TO COME BACK INTO THE HELIUM DRIVE-LINE. THE PUMP WAS IN STANDBY DURING THE PROCEDURE. THE TUBING WAS CLAMPED IMMEDIATELY, AND THE ATTENDING PHYSICIAN WAS CALLED. THE IAB WAS REMOVED WITHOUT INCIDENT WITHIN 20 MINUTES". ANOTHER IAB WAS NOT INSERTED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19059797 ↗
• MalfunctionOct 25, 2023Fluid/Blood Leak; Fluid/Blood Leak

  REPORTED AS, "FAILED IAB, RUST SPECS OBSERVED IN GAS TUBING". AS A RESULT, THE IAB WAS REMOVED. A 2ND IAB WAS NOT INSERTED AS IABP THERAPY WAS NO LONGER NEEDED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18003698 ↗
• InjuryOct 12, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT " IAB ORIGINALLY INSERTED IN ANOTHER HOSPITAL. BALLOON WAS REMOVED AT OUR HOSPITAL. IT WAS DIFFICULT FOR THE CARDIAC SURGEON WHEN REMOVING THE BALLOON: BALLOON WAS BLOCKED IN THE STENT". ADDITIONAL INFORMATION RECEIVED STATES "THE BALLOON WAS REMOVED FOLLOWING ACUTE LIMB ISCHEMIA. DUE TO THE DIFFICULTIES ENCOUNTERED DURING REMOVAL, THE IAB + STENT HAD TO BE REMOVED AS A SINGLE UNIT. DURING THE INCIDENT, THE PATIENT HAD TO BE COMPRESSED FOR 30 TO 45 MINUTES AFTER REMOVAL". 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: Insufficient Information; Ischemia

  MAUDE report 17922958 ↗
• MalfunctionOct 9, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT "THE INTRA-AORTIC COUNTERPULSATION BALLOON DID NOT WORK PROPERLY, THE 'YELLOW CAP' NORMALLY INTEGRATED INTO THE REMOVE PART REMAINED ATTACHED TO THE BALLOON. SO IT WAS IMPOSSIBLE TO REMOVE IT. THE COUNTERPULSATION BALLOON HAD TO BE CHANGED, SO NEW KIT HAD TO BE USED AND OPENED". THE 2ND IAB WAS INSERTED SUCCESSFULLY. 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: Insufficient Information

  MAUDE report 17899912 ↗
• InjuryAug 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA A MEDWATCH REPORT THAT AFTER INSERTION OF THE IAB, "THE TUBING STARTED TO BACK-FILL WITH BLOOD; THE BALLOON PUMP WAS THEN REMOVED AND A HOLE WAS NOTED IN THE BALLOON AT THAT TIME. WHEN THE BALLOON WAS REMOVED THE FEMORAL ARTERY WAS TORN REQUIRING A VASCULAR SURGEON TO COME IN TO REPAIR THE LEFT FEMORAL ARTERY". ADDITIONAL INFORMATION STATES THAT "WHEN WITHDRAWING IT THE TEAM DIDN'T DEFLATE SUFFICIENTLY AND THEREFORE CAUSED THE TEAR IN AORTA. PATIENT POST-PRIMARY REPAIR OF (L) COMMON FEMORAL ARTERY AND TO ICU IN STABLE CONDITION." AS A RESULT, A 2ND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE.

  Patient problems: Cardiac Perforation; Needle Stick/Puncture

  MAUDE report 17567773 ↗