ARROW IPN000262Recalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00801902002686), received between Jul 9, 2018 and Nov 24, 2025 — classified as 3 deaths, 14 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (40 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 170 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER INSERTION OF IABC , IT DID NOT INFLATED". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED INTO A DIFFERENT 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 23632971 ↗
• MalfunctionNov 21, 2025Difficult to Advance; Difficult to Advance

  THE REPORT STATES "THE CATHETER STUCK IN SHEATH AND IT WAS DIFFICULT TO DRAW BLOOD BACK. CHANGE THE NEW CATHETER". THE NEW 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 23622041 ↗
• MalfunctionNov 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " AFTER THE CATHETER INSERTED, THE PUMP ALARMED 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 23533745 ↗
• MalfunctionNov 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTION PROCESS IN THE HOSPITAL'S INTERVENTIONAL ROOM FOR A PATIENT, IT WAS FOUND THAT THE BLOOD IN HELIUM PATHWAY. AFTER THE CATHETER REMOVED, IT WAS DISCOVERED THAT THE CENTRAL LUMEN WAS BROKEN. CHANGE THE NEW CATHETER AND THE PROCEDURE CONTINUED NORMALLY". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525736 ↗
• MalfunctionNov 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED, THE PUMP ALARMED BALLOON HIGH-PRESSURE ALARM. THE BALLOON WAS FOUND THAT CAN NOT INFLATE COMPLETELY AFTER REMOVE THE CATHETER. 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 23511313 ↗
• MalfunctionNov 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " THE NURSE NOTICED AN ABNORMAL BLOOD PRESSURE WAVEFORM ON THE IABP DISPLAY SCREEN. UPON INSPECTION, IT WAS FOUND THAT THERE WAS BLEEDING AT THE CONNECTION OF THE Y-SHAPED CONNECTION. THE PATIENT'S CONDITION WAS STABLE, SO THE DOCTOR REMOVED THE CATHETER. THE PATIENT WAS IN GOOD CONDITION". ADDITIONAL INFOMATION STATES THAT 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478496 ↗
• InjuryOct 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "BLOOD IN HELIUM TUBING". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REPLACED 2 HOURS LATER. 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 23367306 ↗
• MalfunctionOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED ", DURING THE CATHETERIZATION PROCEDURE IN THE HOSPITAL'S INTERVENTIONAL ROOM, IT WAS FOUND THAT BLOOD IN HELIUM PATHWAY. AFTER REPLACING IT WITH A NEW CATHETER, THE PROCESS CONTINUED NORMALLY". 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 23342315 ↗
• MalfunctionOct 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER THE CATHETER WAS INSERTED INTO THE PATIENT ONE HOUR, THE PUMP FREQUENT ALARMED HELIUM GAS LEAKAGE. AFTER CHECK, IT WAS FOUND THAT THERE WERE SIGNS OF TISSUE FLUID AND BLOOD RED IN THE HELIUM GAS PIPELINE. TO ENSURE THE PATIENT'S SAFETY, THE CATHETER WAS IMMEDIATELY REMOVED AND A NEW ONE 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 23254340 ↗
• MalfunctionSep 24, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED "BALLOON HAD RESISTANCE WHILE ADVANCING OVER THE WIRE AND THROUGH THE SHEATH". ADDITIONAL INFORMAITON STATES 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 23135237 ↗
• MalfunctionSep 16, 2025Inflation Problem; Inflation 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 23066201 ↗
• MalfunctionSep 10, 2025Inflation Problem; Inflation 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 23016321 ↗
• MalfunctionSep 9, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "THE CATHETER INSERTED INTO THE PATIENT SUCCESSFULLY. AFTER 2 HOURS, THE PUMP REPEATEDLY ALARM HELIUM LEAKAGE, 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 23006888 ↗
• MalfunctionAug 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, "THE CATHETER CAN'T BE INSERTED INTO THE PATIENT". ADDITIONAL INFORMAITON STATES 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 22808722 ↗
• MalfunctionAug 14, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "WHILE TRYING TO INTRODUCE THE GUIDEWIRE INTO THE BALLOON IT WAS GOING VERY TIGHT, SO TRIED TO PULL OUT THE GUIDEWIRE IT GOT STUCK IN THE BALLOON". ADDITIONAL INFORMATION STATES 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 22806653 ↗
• MalfunctionAug 11, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE INTERFACE OF THE HELIUM GAS PIPELINE OF THE CATHETER IS LEAKING". ADDITIONAL INFORMATION STATES 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 22775837 ↗
• MalfunctionAug 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " THE PERFUSIONIST REPORTED AN IAB REDIGUARD WHICH DID NOT FULLY INFLATED THE BALLOON AND THEREFOR GAVE ALARMS AND NO SUFFICIENT CARDIAC SUPPORT. CARDIOLOGIST PLACED THE IAB AND AFTER THEY STARTED THE IABP THE BALLOON DID NOT FUNCTION AS MENTIONED. THEY REMOVED THIS IAB AND PLACED A SECOND REDIGUARD, WHO FUNCTIONED PERFECTLY. NO FURTHER HARM WAS DONE TO THE PATIENT". 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 22700662 ↗
• MalfunctionAug 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON WOULD NOT INFLATE. THE BALLOON WAS REMOVED, AND A NEW BALLOON WAS OPENED. NO SAFETY CONCERNS WITH PATIENT". 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 22688451 ↗
• MalfunctionJul 23, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. AFTER 10 MINUTES, THE PUMP ALARM HELIUM LEAKAGE. GAS WAS WITHDRAWN FROM THE HELIUM PIPELINE AND BLOOD WAS FOUND. REMOVE THE CATHETER AND CHANGE THE 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 22579424 ↗
• MalfunctionJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. AFTER 1 DAY OF TREATMENT, THE PUMP ALARM HELIUM LEAKAGE, AND BLOOD WAS FOUND, WHICH WAS DETERMINED TO BE DUE TO THE BALLOON RUPTURE. THE CATHETER WAS IMMEDIATELY REMOVED". ADDITIONAL INFORMATION STATES 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576690 ↗
• MalfunctionJul 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. AFTER 1 DAY OF TREATMENT, THE PUMP ALARM HELIUM LEAKAGE. GAS WAS WITHDRAWN FROM THE HELIUM PIPELINE AND BLOOD WAS FOUND. THEREFORE, A NEW BALLOON WAS IMMEDIATELY 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 22576572 ↗
• MalfunctionJul 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. AFTER 7 DAYS OF TREATMENT, THE PUMP ALARM HELIUM LEAKAGE AND AN EXCESSIVELY HIGH BASELINE. A SYRINGE WAS USED TO WITHDRAW GAS FROM THE HELIUM PIPELINE. NO BLOOD OR TISSUE FLUID WAS FOUND. TO ENSURE THE PATIENT'S SAFETY, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS INSERTED. THE BALLOON WAS FOUND TO HAVE SIGNS OF BENDING". 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 22575286 ↗
• MalfunctionJul 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER A PERIOD OF COUNTERPULSATION TREATMENT, THE PUMP ALARM HELIUM LEAKAGE. UPON OBSERVATION, THERE WAS BLOOD IN THE HELIUM PIPELINE OF THE CATHETER. THE COUNTERPULSATION TREATMENT WAS IMMEDIATELY STOPPED AND THE CATHETER WAS REMOVED". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS NOT 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 22566661 ↗
• MalfunctionJul 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER 2 HOURS OF TREATMENT, THE PUMP ALARM HELIUM LEAKAGE. GAS WAS WITHDRAWN FROM THE HELIUM PIPELINE AND BLOOD WAS FOUND. THEREFORE, A NEW CATHETER WAS IMMEDIATELY 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 22566626 ↗
• MalfunctionJul 22, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED, "THE CATHETER INSERTED INTO THE PATIENT. AFTER 10 MINUTES, THE PUMP ALARM HELIUM GAS LEAKAGE AND EXCESSIVE PRESSURE. GAS WAS ASPIRATED FROM THE HELIUM GAS PIPELINE, BUT NO BLOOD OR TISSUE FLUID WAS FOUND. THE PUMP WAS RESTARTED, BUT IT STILL ALARM HELIUM GAS LEAKAGE AND EXCESSIVE PRESSURE. TO ENSURE THE PATIENT'S SAFETY, A NEW CATHETER WAS REPLACED. AFTER REMOVAL, IT WAS FOUND THAT THERE WAS KINKED IN THE MIDDLE SECTION OF THE BALLOON". 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 22566296 ↗