ARROW IPN000263Recalls & reported problems

Summary

The FDA's MAUDE database contains 347 adverse event reports that list this exact device (DI 00801902002679), received between Jul 15, 2018 and Nov 21, 2025 — classified as 3 deaths, 18 injuries, 326 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (48 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 347 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Entrapment of Device; Entrapment of Device

  THE REPORT STATES "DURING THE CATHETER INSERTION PROCEDURE, THE END OF THE BALLOON STUCK IN SHEATH. 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 23622118 ↗
• MalfunctionNov 19, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "(B)(6) 2025, THE CATHETER INSERTED INTO THE PATIENT. THE PUMP ALARMED HIGH PRESSUREAND ANGIOGRAPHY SHOWED THAT THE BALLOON HAD NOT INFLATE COMPLETELY". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596817 ↗
• MalfunctionNov 11, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED ", AN IABC IMPLANTATION WAS PERFORMED. DURING THE IMPLANTATION PROCESS, THE CATHETER WAS DIFFICULT TO INSERT AND COULD NOT BE IMPLANTED. CHANGE THE NEW CATHETER". ADDITIONAL INFORMATION STATES THAT THE IAB WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525702 ↗
• MalfunctionNov 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE PUMP ALARMED BALLOON HIGH-PRESSURE AND HELIUM LOSS. THE BALLOON WAS FOUND THAT CANNOT INFLATE COMPLETELY AFTER REMOVE THE 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 23478446 ↗
• MalfunctionNov 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE INFLATION AND PRESSURIZATION EFFECT WAS NOT ACHIEVED AFTER CATHETER INSERTED. 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 23478121 ↗
• MalfunctionOct 24, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED "CLOTTED CENTRAL LUMEN". 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 23381236 ↗
• MalfunctionOct 21, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED ", IN THE PROCESS OF INSERTION, THE CATHETER WAS STUCK IN SHEATH. THE TIP OF THE BALLOON WAS FOUND BENT AFTER REMOVED, CHANGE 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 23347108 ↗
• MalfunctionOct 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED "IN THE INTERVENTIONAL OPERATING ROOM OF THE HOSPITAL, DURING THE CATHETER INSERTED INTO THE PATIENT, THE TIP OF THE BALLOON WAS BENT. AFTER MULTIPLE ATTEMPTS TO PLACE IT, IT STILL COULD NOT BE POSITIONED PROPERLY. 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 23347073 ↗
• MalfunctionOct 21, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED " AFTER STARTING THE PUMP, AN ALARM WAS TRIGGERED. MULTIPLE ATTEMPTS WERE MADE TO START IT, AND EVEN ADJUSTING THE POSITION OF THE BALLOON STILL RESULTED IN AN ALARM. AFTER DISCUSSION, THE CATHETER WAS REMOVED AND A NEW CATHETER WAS REPLACED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23347037 ↗
• MalfunctionOct 20, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ", IT WAS FOUND THAT BLOOD IN HELIUM PATHWAY AND THE PUMP NOT ALARMED. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342463 ↗
• MalfunctionOct 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE DOCTOR NOTICED BLOOD SEEPING FROM A CRACK IN THE BIFURCATE LUER, .AFTER CHANGE A NEW CATHETER, THE PROCEDURE 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 23342300 ↗
• MalfunctionOct 9, 2025Break; Break

  IT WAS REPORTED "AFTER OPENING THE PACKAGE, THE CATHETER HAD ALREADY EXPANDED AND COULD NOT BE USED TO CREATE NEGATIVE PRESSURE FOR RETRACTION, AND IT WAS IMPOSSIBLE TO INSERT IT INTO THE PUNCTURE SHEATH. IT WAS SUSPECTED THAT THE CATHETER HAD BEEN DAMAGED. A NEW CATHETER WAS REPLACED AND THE OPERATION WAS CONTINUED". NO PATIENT INJURYU OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257567 ↗
• MalfunctionOct 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ", AFTER THE CATHETER WAS INSERTED, THE PATIENT RETURNING TO THE WARD, THE PUMPFREQUENTLY ALARMED FOR HELIUM LEAKAGE AND STOPPED COUNTERPULSATION. THE NEW CATHETER WAS IMMEDIATELY REPLACED AND IT OPERATED 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 23192221 ↗
• InjurySep 25, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY. CHANGE THE NEW CATHETER". ADDITIONAL INFORMATION STATES THAT THE SECOND IAB CATHETER USED WAS INSERTED INTO A DIFFERENT INSERTION SITE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23143812 ↗
• InjurySep 19, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED " DETECT BLOOD IN TUBING. SO, THEY ATTEMPTED SUBCUTANEOUS REMOVAL OF BALLOON. WHEN BALLOON WAS HALF OUTSIDE, THEY RECOGNISED THE BALLOON WAS TORN AND STUCK. IABC WAS NOT COMING OUT. THEY DECIDED TO SNARE IT FROM CONTRALATERAL SIDE AND THEY REALISED THE CATHETER CAN NOT BE COMPLETELY PULLED OUT FROM CONTRALATERAL SIDE. SO, THE CATHETER WAS CUT BELOW BALLOON AND PART SHARED SNARED OUT FROM CONTRALATERAL SIDE AND BELOW PART FROM IPSILATERAL". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER WAS NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096662 ↗
• MalfunctionSep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT IN ICU ROOM. DURING THE INSERTION PROCESS, BLOOD WAS OBSERVED FLOWING OUT FROM THE DISTAL END OF THE BALLOON, SUGGESTING A RUPTURE OF THE BALLOON. AS A RESULT, THE CATHETER WAS REMOVED 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 23057549 ↗
• MalfunctionSep 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED " AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP IMMEDIATELY ALARMED THAT HELIUM GAS MIGHT BE LEAKING. AFTER INVESTIGATION, IT WAS FOUND THAT THERE WAS BLOOD IN HELIUM PATHWAY. THE CATHETER WAS IMMEDIATELY REMOVED 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 23057544 ↗
• MalfunctionSep 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT "ON (B)(6) 2025, THE CATHETER WAS INSERTED INTO THE PATIENT IN ICU ROOM. DURING THE INSERTION PROCESS, BLOOD WAS OBSERVED FLOWING OUT FROM THE DISTAL END OF THE BALLOON, SUGGESTING A RUPTURE OF THE BALLOON. AS A RESULT, THE CATHETER WAS REMOVED AND CHANGE THE NEW ONE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23038395 ↗
• MalfunctionSep 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER INSERTED INTO THE PATIENT SUCCESSFULLY. AFTER 10 MINUTES, THE PUMP REPEATEDLY ALARM HELIUM LEAKAGE, BLOOD WAS FOUND WHEN THE SYRINGE WAS USED TO DRAW BACK FROM THE HELIUM GAS PIPELINE, INDICATING THAT THE BALLOON WAS DAMAGED.CHANGE THE NEW CATHETER". 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 23006822 ↗
• MalfunctionSep 8, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED " BALLOON WAS LEAKING AFTER INSERTION". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE/STILL CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999279 ↗
• MalfunctionSep 3, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED ", THE CATHETER WAS INSERTED INTO THE PATIENT, WHEN THE NURSE ASPIRATE BEFORE FLUSHING THE CATHETER, CONTINUOUS BUBBLES APPEARED IN THE LIQUID PIPE. THE AP SENSOR WAS REMOVED TO RELEASE THE AIR AND THE PIPE WAS RECONNECTED. HOWEVER, WHEN THE SUCTION WAS PERFORMED AGAIN, THERE WERE STILL BUBBLES. THE AP SENSOR AND THE EXTENSION TUBE WERE REPLACED, BUT THE SITUATION DID NOT IMPROVE. AFTER COMMUNICATING WITH THE ENGINEER, IT WAS SUSPECTED THAT THE LEAKAGE AT THE Y-SHAPED CONNECTION CAUSED THIS SITUATION. 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 22955324 ↗
• MalfunctionAug 22, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED "THE CATHETER CAN NOT BE INSERTED". 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 22872276 ↗
• MalfunctionAug 15, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED ", THE CATHETER CAN'T INSERTED TO REACH THE RIGHT POSITION. 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 22815834 ↗
• MalfunctionAug 14, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED ", THE CATHETER CAN'T BE INSERTED INTO THE PATIENT". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPROTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22807362 ↗
• MalfunctionAug 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " AFTER THE CATHETER INSERTION, 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 22785177 ↗