ARROW IPN000254Recalls & reported problems

Summary

The FDA's MAUDE database contains 441 adverse event reports that list this exact device (DI 00801902007247), received between Jul 17, 2018 and Nov 20, 2025 — classified as 5 deaths, 43 injuries, 393 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (132 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 441 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED "SUSPECTED IAB LEAK". 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 23606953 ↗
• MalfunctionNov 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "IAB RUPTURE". 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".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586705 ↗
• MalfunctionNov 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE BALLOON MEMBRANE DID NOT INFLATE WHEN STARTING THE COUNTERPULSATION THERAPY. THE BALLOON HAD TO BE REMOVED". 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 23555201 ↗
• MalfunctionOct 28, 2025Leak/Splash; Leak/Splash

  THE REPORT STATES "FAILED LEAK TEST- POTENTIAL RUPTURE". THE REPORT FURTHER STATES THAT "PATIENT WAS HAVING MULTIPLE HELIUM LOSS 2 ALARMS X9, FROM 605 TO 650, PRIOR TO BEING CONNECTED. [USER] CHECKED ALL CONNECTIONS, THEY WERE TIGHT AND SECURE, THE PATIENT HAD A 40CC EC IABC (GS40886). WAVEFORMS APPROPRIATE UPON CONNECTION, 2 MORE ALARMS WENT OFF WHEN CONNECTED, BOTH HELIUM LOSS 2. DECIDED TO DO A LEAK TEST, THIS INDICATED A POTENTIAL ISSUE ON THE CATHETER END. DISCUSSED WITH [THE USER] THIS COULD BE A POTENTIAL RUPTURE AND TO CONTACT HER PROVIDERS TO DISCUSS REMOVAL AND/OR REPLACEMENT DEPENDING ON THEIR PLAN OF CARE". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23407479 ↗
• MalfunctionOct 7, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED "HIGH PRESSURE ALARMS, IAB RUPTURE". 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 23235088 ↗
• MalfunctionOct 7, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "IAB RUPTURE". 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: Insufficient Information

  MAUDE report 23235007 ↗
• MalfunctionSep 26, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED "HIGH PRESSURE ALARM AT INSERTION. REMOVED AND REPLACED WITH A NON-FIBER IABC'. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PAITENT'S CURRENT CONDITION IS UNKNOWN. 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 23154191 ↗
• MalfunctionSep 25, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "HELIUM LOSS 2 ALARMS, X10/1HR - FAILED LEAK TEST". ADDITIONAL INFORMATION STATES THAT THE USER WAS PREPARING FOR REMOVAL, HOWEVER IT IS UNKNOWN WHEN/IF THE IAB CATHETER WAS REMOVED AND/OR REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144240 ↗
• MalfunctionSep 15, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "THE DOCTOR HAD IS THE SOFT DILATORS WHERE THE TIP OF THE 2 DILATORS WERE BROKEN SINCE THEY WERE VERY SOFT AND IT WASN'T THE FIRST TIME". THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR#'S: 3010532612-2025-00949, 3010532612-2025-00950.

  Patient problems: Insufficient Information

  MAUDE report 23057503 ↗
• MalfunctionSep 15, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "THE DOCTOR HAD IS THE SOFT DILATORS WHERE THE TIP OF THE 2 DILATORS WERE BROKEN SINCE THEY WERE VERY SOFT AND IT WASN'T THE FIRST TIME". THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR#'S: 3010532612-2025-00950, 3010532612-2025-00948.

  Patient problems: Insufficient Information

  MAUDE report 23057493 ↗
• MalfunctionSep 15, 2025Connection Problem; Connection Problem

  IT WAS REPORTED "THE DOCTOR HAD IS THE SOFT DILATORS WHERE THE TIP OF THE 2 DILATORS WERE BROKEN SINCE THEY WERE VERY SOFT AND IT WASN'T THE FIRST TIME". THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR#'S: 3010532612-2025-00949, 3010532612-2025-00948.

  Patient problems: Insufficient Information

  MAUDE report 23057487 ↗
• MalfunctionSep 5, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED " PERSISTENT POSSIBLE HELIUM LOSS ALARMS WITH SUSPECTED IAB RUPTURE". ADDITIONAL INFORMATION 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 22976536 ↗
• MalfunctionAug 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "IABC ABRASION/RUPTURE. SHE PLACED ME ON SPEAKER WITH THE MD. A LARGE AMOUNT OF BLOOD WAS NOTED IN THE HELIUM DRIVE LINE IMMEDIATELY AFTER INSERTION ON INITIATION OFPUMPING. ALARMS WERE NOTED ON THE PUMP. MD DISCUSSED WHY THIS COULD OCCUR AND COMMENTED THAT HE NOTEDDIFFICULTY DURING INSERTION DUE TO SEVERE ILIAC DISEASE". ADDITIONAL INFORAMTION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851475 ↗
• MalfunctionAug 20, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "POSSIBLE IABC ABRASION PERSISTENT HELIUM LOSS 2 ALARMS". 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 "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851406 ↗
• MalfunctionAug 18, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "POSSIBLE HE LOSS 2 ALARMS. [THE USER] STATES THEY ARE HAPPENING EVERY 2 MINUTES AND HAS HAD 4 TOTAL. [THE USER] VERIFIED THERE IS NO BLOOD IN DRIVELINE AND THAT ALL CONNECTIONS ARE TIGHT. THE MD MANAGING THE PATIENT IS AT BEDSIDE. LEAK TEST SHOWED IAB POSITIVE FOR A LEAK". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT WAS TREATED WITH OTHER METHODS IN LIEU OF IAB THERAPY. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828058 ↗
• MalfunctionAug 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "RUPTURED IAB". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815687 ↗
• MalfunctionAug 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED VIA USER REPORT " UPON UNPACKING THE DEVICE, THE OPTICAL FIBER WAS FUNCTIONING PROPERLY; HOWEVER, THE BALLOON WAS SUSPECTED TO HAVE BEEN IMPROPERLY WRAPPED. THE BALLOON APPEARED TAPERED, PINCHED UNDER THE METAL PART, AND THE EDGES WERE NOT PARALLEL. DECISION WAS MADE NOT TO INSERT THE BALLOON FOR AND REQUEST FOR AN INVESTIGATION FROM TELEFLEX. DEVICE WAS REPLACED WITH ANOTHER BALLOON FROM THE SAME REFERENCE. THERE WERE NO CONSEQUENCES FOR THE PATIENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22815617 ↗
• MalfunctionJul 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "IAB FAILED LEAK TEST, SUSPECTED ABRASION". ADDITIONAL INFORMATION STATES THE IAB 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 22396872 ↗
• MalfunctionJun 27, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED "ANDNOTICED BLOOD BACKING UP AT THE CATHETER'S CENTRAL LUMEN CONNECTION IN THE TELEFLEX PRESSURE TUBING ATTACHMENT(THE SHORT ONE WITH STOPCOCK), BUT THEN NOTED THAT TUBING WAS CRACKED AND WAS SEPARATING AT DISTAL ATTACHMENTAND LEAKING BLOOD. [USER] STATED "SOMEONE MAY HAVE USED A KELLY CLAMP ON IT," BUT OTHER STAFF REPORTING TUBING "EASILY SEPARATED ON ITS OWN". ADDITIONAL INFORMAITON STATES TO CONTINUE THERAPY THE "PRESSURE TUBING CONNECTED DIRECTLY TO THE CENTRAL LUMEN". THE PATIENTS CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22345202 ↗
• MalfunctionJun 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED "A PATIENT WITH STEMI AND PLACK RUPTURE IN LEFT MAIN. PCI WAS PLANNED AND THE PATIENT CRASHED WHEN STENTING AND CPR STARTED. AFTER A WHILE THE TEAM DECIDED TO USE IABP. THE FIRST BALLOON CATHETER DIDN'T PASSED THE INTRODUCER,SUSPICION OF OVERTWISTED BALLOON WRAP.IT WAS NOTICED WHEN THE CATHETER DIDN'T PASS THROUGH THE INTRODUCER. A SECOND ATTEMPT WITH A NEW IABP CATHETER PASSED THE INTRODUCER BUT THE PATIENT HAD ALREADY TURNED WORSE, AND THE TEAM STOPPED ALL FURTHER INTERVENTION, AND THE PATIENT DIDN'T MAKE IT AND PASSED AWAY. ACCORDING TO TREATING PHYSICIAN DR RAAFET QASIM THE PRODUCT DID NOT CONTRIBUTED TO THE PATIENTS DEATH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22238075 ↗
• MalfunctionJun 16, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE INTERVENTIONAL TECHNICAL PLATFORM INFORMED US OF A WITHDRAWAL OF THE BALLOON THE DAY AFTER THE INSTALLATION BECAUSE OF A LEAK". ADDITIONAL INFORMATION STATES "DURING BALLOON REMOVAL, THE PATIENT HAD A CONCOMITANT HEMODYNAMIC FAILURE AS WELL AS A TRANSITION TO AF. THE PATIENT DIED ON (B)(6) 2025, THE DAY AFTER THE INCIDENT". THE CUSTOMER ALSO STATES "THE CAUSE OF DEATH WAS CARDIOGENIC SHOCK". THIS COMPLAINT HAS BEEN OPENED DUE TO ADDITIONAL INFORMATION THAT STATED, " THE DOCTOR TOLD ME THAT HE ASSUMED THE BALLOON WAS DEFECTIVE BECAUSE HE HAD DIFFICULTY INFLATING IT INITIALLY. " PLEASE SEE ASSOCIATED MDR#: 3010532612-2025-00512.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211225 ↗
• MalfunctionJun 9, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "REPEATED HELIUM LOSS 2 ALARMS. NO BLOOD NOTED IN DRIVELINE. ALARMS OCCURRINGEVERY 30S-1MIN. LEAK TEST CONDUCTED AND IAB FAILED. SUSPECTED ABRASION". THE IAB 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 22169014 ↗
• MalfunctionJun 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AN INFLATION WAS PERFORMED ON THE OPERATING TABLE, AND AN ANOMALY WAS DETECTED IN THE COMPLETENESS OF THE INFLATION ITSELF".HOW THE ISSUE WAS RESOLVED, THE OUTCOME OF THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22153433 ↗
• MalfunctionJun 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "FAILURE TO UNWRAP". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED TO CONTINUE THERAPY. 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 22153405 ↗
• MalfunctionJun 5, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "DELAYED UNWRAPPING". ADDITIONAL INFORMATION STATES THAT MANUAL INFLATION WAS PREFORMED AND THE IAB REMAINED IN PLACE AND CONTINUED TO SUPPORT 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 22153370 ↗