ARROW IPN039783Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801902145649), received between Aug 11, 2022 and Apr 9, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 reports).

2 other recalls cover devices cleared under the same FDA submission (K981660); they may or may not involve this specific model.

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED "AFTER THE CATHETER INTO THE PATIENT, THE BLOOD WAS FOUND IN HELIUM PATHWAY. CHANGE THE NEW CATHETER". 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 24831431 ↗
• MalfunctionMar 25, 2026Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY, CHANGE THE NEW CATHETER." 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 24687835 ↗
• MalfunctionMar 24, 2026Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY, CHANGE THE NEW CATHETER". 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 24674852 ↗
• MalfunctionMar 12, 2026Inflation Problem

  IT WAS REPORTED "IAB DID NOT UNWRAP". 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 "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24578765 ↗
• MalfunctionMar 9, 2026Inflation Problem

  IT WAS REPORTED "IABC CANNOT INFLATE WHILE INSERT IN PATIENT". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT WAS MEDICALLY MANAGED WITHOUT THE IAB CATHETER. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24545782 ↗
• MalfunctionMar 3, 2026Material Twisted/Bent

  IT WAS REPORTED "DUE TO SHAFT BENDING, THE BALLOON BECOMES INVERTED AND CANNOT BE FULLY INFLATED". 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 24495484 ↗
• MalfunctionFeb 6, 2026Device Alarm System

  IT WAS REPORTED " DURING AN URGENT ANGIOPLASTY PROCEDURE, UPON SWITCHING ON THE MACHINE, AUDIBLE AND VISUAL ALARMS WERE DETECTED. AFTER PERFORMING THE STANDARD CHECKS, THE BALLOON CATHETER WAS POSITIONED IN THE AORTA AND CONNECTED TO THE MACHINE, RESULTING IN THE ABSENCE OF COUNTERPULSATION. GIVEN THE URGENCY OF THE PROCEDURE DUE TO THE PATIENT'S INSTABILITY, THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME TYPE BUT FROM A DIFFERENT LOT. ONCE POSITIONED AND CONNECTED, DESPITE THE PERSISTENCE OF THE ALARM SIGNAL, IT PERFORMED ITS FUNCTION, ALLOWING THE PROCEDURE TO BE COMPLETED, AFTER WHICH IT WAS REMOVED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279548 ↗
• MalfunctionFeb 6, 2026Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY, CHANGE THE NEW CATHETER". 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 24279453 ↗
• MalfunctionJan 23, 2026Inflation Problem

  IT WAS REPORTED "IABC UNABLE TO INFLATE AFTER INSERTION. DEVICE REMOVED AND NOTED A HOLE IN THE BALLOON. A SECOND BALLOON WASINSERTED VIA SAME ACCESS, RIGHT FEMORAL APPROACH.". NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24163149 ↗
• MalfunctionJan 14, 2026Difficult to Insert

  IT WAS REPORTED ", THE CATHETER INSERTED INTO THE PATIENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE CATHETER INTO THE BODY AFTER THE GUIDEWIRE WAS POSITIONED, AND UPON BALLOON PLACEMENT, NO PRESSURE WAS DISPLAYED IN THE CENTRAL LUMEN. THE PROCEDURE WAS COMPLETED AFTER CHANGE THE NEW CATHETER". 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 24067321 ↗
• MalfunctionJan 9, 2026Inflation Problem

  IT WAS REPORTED " AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BALLOON COULD NOT INFLATE COMPLETELY. AN EMERGENCY METHOD WAS ATTEMPTED: INFLATING THE BALLOON WITH A SYRINGE. HOWEVER, THERE WAS SIGNIFICANT RESISTANCE, AND DSA IMAGING SHOWED THAT THE BALLOON STILL COULD NOT BE INFLATE. SUBSEQUENTLY, THE CATHETER WAS REPLACED WITH NEW ONE". 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 24020154 ↗
• MalfunctionJan 2, 2026Leak/Splash

  IT WAS REPORTED "THE CATHETER WAS FOUND BENT AND THE PUMP ALARMED MULTIPLE ALERTS WITHIN THREE MINUTES. CHANGE THE NEW CATHETER". 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 23944136 ↗
• MalfunctionDec 22, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "CANNOT UP FERMORAL ARTERY TO AORTIC ROOT TRUNK, IT NEED TO MANAGE BY MEDICINE".ADDITIONAL INFORMATION STATES THATS THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23865995 ↗
• MalfunctionDec 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP FREQUENT ALARMS HIGH PRESSURE. AFTER THE CATHETER REMOVED, THE FRONT ONE-THIRD OF THE BALLOON FAILED TO INFLATE. CHANGE THE NEW CATHETER". 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 23850088 ↗
• MalfunctionSep 9, 2022Improper Flow or Infusion; Improper Flow or Infusion

  COMPLAINT FROM MEDSUN REPORT: IT WAS REPORTED "EARLY 60'S FEMALE WITH HISTORY OF DIABETES, HYPERTENSOIN AND ACUTE CHEST PAIN. PROCEDURE: CARDIAC CATH, PERCUTANEOUS INTERVENTION, STENT PLACEMENT AND BALLOON ANGIOPLASTY. WHILE DOING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. DEVICE REMOVED AND ANOTHER ONE USED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15390464 ↗
• MalfunctionAug 11, 2022Inflation Problem

  EARLY 60¿S FEMALE WITH HISTORY OF DIABETES, HYPERTENSION AND ACUTE CHEST PAIN. PROCEDURE: CARDIAC CATH, PERCUTANEOUS INTERVENTION, STENT PLACEMENT AND BALLOON ANGIOPLASTY. WHILE DOING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE. DEVICE REMOVED AND ANOTHER ONE USED WITHOUT DIFFICULTY. NO KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL, ARROW (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15209655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K981660. One submission often covers many models, so check the product and lot details in each record.

• Z-1061-2016 · Feb 10, 2016 · Terminated
  RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1063-2016 · Feb 10, 2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during dia