ARROW IPN039782Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10801902145625), received between Dec 15, 2025 and May 6, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (5 reports).

27 other recalls cover devices cleared under the same FDA submission (K000729); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Positioning Problem

  IT WAS REPORTED THAT "WHEN THE PHYSICIAN INSERTED THE BALLOON CATHETER INTO THE PATIENT, IT WAS FOUND THAT THE CATHETER LACKED SUFFICIENT SUPPORT". AS A RESULT THE IAB WAS REMOVED AND REPLACED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 25093502 ↗
• MalfunctionMar 4, 2026Inflation Problem

  IT WAS REPORTED "IAB DID NOT UNWRAP". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND IAB WAS PLACED IN THE SAME INSERTION SITE AS THE FIRST. NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511894 ↗
• MalfunctionMar 4, 2026Material Integrity Problem

  IT WAS REPORTED ", DURING THE COUNTERPULSATION USE, THE PROXIMAL BUTTERFLY WING DETACHED FROM THE BIFURCATION OF THE CATHETER BODY. THE CATHETER HAS NOW BEEN REMOVED". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24511677 ↗
• MalfunctionMar 3, 2026Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. AFTER ANOTHER PUMP WAS REPLACED, BUT THE SAME ALARM PERSISTED. THE CATHETER WAS REPLACED AND FUNCTIONED 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 24495658 ↗
• MalfunctionMar 2, 2026Device Alarm System

  IT WAS REPORTED "AFTER CATHETER INSERTED, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. AFTER TROUBLESHOOTING CONNECTION AND LEAKAGE ISSUES, ANOTHER PUMP WAS REPLACED, BUT THE SAME ALARM PERSISTED. THE CATHETER WAS REPLACED AND FUNCTIONED 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 24482733 ↗
• MalfunctionMar 2, 2026Difficult to Advance

  IT WAS REPORTED "UPON INSERTION OF THE GUIDEWIRE INTO THE BALLOON CATHETER. RESISTANCE WAS NOTED AT THE PROXIMAL Y END TIP OF THE CA THETER. THE PROCEDURE DID NOT PROCEED BECAUSE OF THIS".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 "CRITICAL", THE CUSTOMER DID NOTE THAT THE PATIENT'S CONDITION WAS CRITICAL PRIOR TO THE USE OF THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482457 ↗
• MalfunctionFeb 27, 2026Inflation Problem

  IT WAS REPORTED "THE BALLOON COULD NOT BE FULLY INFLATED.". 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: Insufficient Information

  MAUDE report 24471001 ↗
• MalfunctionFeb 18, 2026Device Alarm System

  IT WSAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE 2. 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 24376990 ↗
• MalfunctionFeb 16, 2026Failure to Unfold or Unwrap

  IT WAS REPORTED "BALLOON WAS NOT INFLATING ADEQUATELY". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. IT IS UNKNOWN THE LOCATION OF THE SECOND IAB CATHETER USED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RESPONDED TO OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344204 ↗
• MalfunctionFeb 5, 2026Material Deformation

  IT WAS REPORTED THAT "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE CENTRAL LUMEN DAMAGED." AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO DELAY TO THERAPY. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273098 ↗
• MalfunctionJan 26, 2026Patient Device Interaction Problem

  IT WAS REPORTED "IAB RUPTURE".ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. NO PATIENT INJURY OR CONSEQUENCE.THE PATIENT'S CURRENT CONDITION IS "UNKNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178580 ↗
• MalfunctionJan 13, 2026Difficult to Insert

  IT WAS REPORTED ", THE GUIDE WIRE FAILED TO FUNCTION PROPERLY DURING CATHETER INSERTION". 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 24052802 ↗
• MalfunctionJan 13, 2026Material Deformation

  IT WAS REPORTED "THE DOCTOR FOUND THE SHEATH DAMAGED DURING INSERTION". 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 24052609 ↗
• MalfunctionJan 7, 2026Device Alarm System

  IT WAS REPORTED " THE CATHETER INSERTED INTO THE PATIENT ON THE 12TH, THE PUMP ALARMED 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 23991071 ↗
• MalfunctionJan 7, 2026Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER INTO THE PATIENT SUCCESSFULLY. AFTER 2 HOURS THE BLOOD WAS FOUND IN HELIUM PATHWAY AND THE DOCTOR REMOVED THE CATHETER". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. 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 23989382 ↗
• MalfunctionJan 7, 2026Leak/Splash

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP FREQUENT ALARMS HELIUM LEAKAGE. AFTER REPLACING THREE PUMPS, THE ALARM FOR HELIUM LEAKAGE AND CARDIAC ARREST STILL WENT OFF FREQUENTLY. CHANGE THE NEW CATHETER, AND THE COUNTERPULSATION STARTED NORMALLY. THEN, THE DOCTOR PERFORMED A PRELIMINARY INSPECTION ON THE REMOVED BALLOON. WHEN INFLATED, THE BALLOON PRODUCED BUBBLES IN THE WATER POOL, INDICATING HOLES IN THE BALLOON". 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 23989294 ↗
• MalfunctionJan 5, 2026Material Deformation

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BALLOON FAILED TO INFLATE. AFTER REMOVE THE CATHETER, CENTRAL LUMEN WAS FOUND RUPTURE. THE NEW CATHETER".THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956019 ↗
• MalfunctionDec 29, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " THE BALLOON WOULD NOT INFLATE COMPLETELY". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED. IT IS UNKNOWN IF THE IAB CATHETER WAS REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23908799 ↗
• MalfunctionDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BLOOD WAS FOUND IN THE HELIUM PATHWAY AND THERE IS A HOLE IN THE MIDDLE OF THE BALLOON, AND IT'S LEAKING BLOOD AFTER THE CATHETER REMOVAL." ADDITIONAL INFORMAITON STATES THAT ONCE THE CATHETER WAS REMOVED IT WAS REPLACED. 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 23866251 ↗
• MalfunctionDec 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "DURING THE PROCESS OF IMPLANTING THE CATHETER INTO THE PATIENT, THE BALLOON WAS RUPTURE AND BLOOD WAS FOUND IN HELIUM PATHWAY. 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 23838454 ↗
• MalfunctionDec 17, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED ", DURING THE CATHETER USE, THE PUMP REPORTED THE HELIUM LOSS ALARM. 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 23829472 ↗
• MalfunctionDec 17, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED "IAB NOT FULLY UNWRAPPING". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER "UNWRAPPED ITSELF". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828095 ↗
• MalfunctionDec 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "THE PRODUCT PACKAGE WAS OPENED TO PERFORM THE PUNCTURE AND INSERT THE GUIDEWIRE. UPON PARALLEL WITHDRAWAL OF THE CATHETER, THE FRONT END OF THE CATHETER WAS FOUND TO BE BENT AND DEFORMED. 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 23809672 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000729. One submission often covers many models, so check the product and lot details in each record.

• Z-1879-2024 · Apr 29, 2024 · Open, Classified
  Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
• Z-1880-2024 · Apr 29, 2024 · Open, Classified
  Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
• Z-1056-2016 · Feb 10, 2016 · Terminated
  Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1059-2016 · Feb 10, 2016 · Terminated
  UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1060-2016 · Feb 10, 2016 · Terminated
  UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1058-2016 · Feb 10, 2016 · Terminated
  Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diasto
• Z-1062-2016 · Feb 10, 2016 · Terminated
  Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during di
• Z-1065-2013 · Nov 27, 2012 · Terminated
  Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation th
• Z-1064-2013 · Nov 27, 2012 · Terminated
  Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation t
• Z-0793-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
• Z-0791-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
• Z-0792-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
• Z-0790-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
• Z-0969-2011 · Oct 11, 2010 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
• Z-1210-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counte

…and 12 more.