ARROW IPN000257Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00801902003751), received between Oct 8, 2018 and Nov 25, 2025 — classified as 3 deaths, 19 injuries, 211 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (40 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED " AFTER THE CATHETER INTO THE PATIENT, THE PUMP ALARMED HELIUM LOSS 3. AFTER THE CATHETER WAS REMOVED, IT WAS FOUND THAT THE FRONT END OF THE BALLOON WAS BENT". 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 23644761 ↗
• MalfunctionNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER THE CATHETER INTO THE PATIENT, THE BLOOD WAS FOUND IN HELIUM PATHWAY. AFTER THE CATHETER WAS REMOVED, IT WAS FOUND THAT THE FRONT END OF THE BALLOON WAS BENT". ADDITIONAL INFORMATION STATES THAT THE SAME INSERTION SITE WAS USED FOR THE SECOND IAB 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 23644565 ↗
• InjuryNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE INSERTION OF THE SHEATH TUBE INTO THE BODY, A BEND OCCURRED AND WAS UNABLE TO BE INSERTED INTO THE PATIENT'S BODY". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED IN A DIFFERENT INSERTION SITE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610116 ↗
• MalfunctionNov 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BLOOD WAS FOUND IN HELIUM PATHWAY AND REMOVE DIFFIUCLTY". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532397 ↗
• 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. CHANGE THE NEW CATHETER AND 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 23525890 ↗
• MalfunctionOct 29, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "THE BALLOON FAILED TO DEPLOY, SO IT DID NOT PROVIDE THE NECESSARY CAPACITY TO SUPPORT THE PUMPING OF THE HEART. SEVERAL ATTEMPTS WERE MADE WITHOUT SUCCESS. THEREFORE, THE NEXT DEVICE WAS OPENED, WHICH DEPLOYED CORRECTLY". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23412609 ↗
• MalfunctionOct 27, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT "PATIENT CONDITION DETERIORATED FURTHER IN ICU AROUND 4AM AND EMERGENCY ANGIOGRAM WAS DONE AROUND 5AM. DIAGNOSIS STEMI, PATIENT IN CARDIOGENIC SHOCK. SHEATH WAS PLACED AND GUIDEWIRE WAS ADVANCED WITH NO CHALLENGES. CARDIOLOGISTS EXPERIENCE RESISTANCE WITH PLACING IAB CATH VIA SHEATH (PROVIDED IN SET) OVER GUIDEWIRE (PROVIDED IN SET), ANOTHER IAB30CC KIT WAS OPENED, AND 2ND CATHETER WAS INSERTED SUCCESSFULLY. CRITICAL ILL PATIENT WAS TAKEN BACK TO ICU WITH SUPPORT OF IABP BUT UNFORTUNATELY PASSED AWAY A FEW HOURS LATER IN ICU". THE REPORT FURTHER STATES "PATIENT WAS CRITICALLY ILL BEFORE IABP WAS INSERTED" AND "ANOTHER IAB CATHETER WAS PLACED (ONLY FEW MINUTES DELAY IN FETCHING 2ND PRODUCT OFF SHELF AND PREPARING FOR INSERTION)".

  Patient problems: Cardiogenic Shock

  MAUDE report 23391655 ↗
• MalfunctionOct 21, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "THE PUMP ALARM INDICATED HELIUM LEAKAGE. AFTER CONSULTING WITH THE ENGINEER, AN ATTEMPT WAS MADE TO ADJUST THE POSITION OF THE BALLOON, AND THE PUMP WAS RESTARTED. HOWEVER, THE ALARM OF HELIUM LEAKAGE STILL OCCURRED. AFTER REPLACING THE NEW CATHETER, THE PUMP RESUMED NORMAL OPERATION. WHEN THE FIRST CATHERER WAS REMOVED, IT WAS FOUND THAT THE FRONT SECTION HAD BEEN BENT AND COULD NOT BE RESTORED TO ITS ORIGINAL STATE". 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 23347045 ↗
• InjuryOct 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THROMBOSIS WAS FOUND INSIDE THE CATHETER, AND IT WAS CONSIDERED THAT THE CATHETER HAD RUPTURED. THE CATHETER WAS REMOVED, BUT IT WAS FOUND TO BE DIFFICULT TO REMOVE. AN EMERGENCY OPERATION WAS PERFORMED IN THE OPERATING ROOM FOR EXPLORATION". ADDITIONAL INFORMAITON STATES THAT ONCE THE CATHETER WAS REMOVED IT WAS NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303828 ↗
• MalfunctionOct 15, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR COSNEQUENECE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 23283848 ↗
• MalfunctionOct 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "2ND IAB RUPTURE". ADDITIONAL INFORMAITON STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN". PLEASE SEE ASSOCIATED MDR#: 3010532612-2025-00980.

  Patient problems: Insufficient Information

  MAUDE report 23268113 ↗
• MalfunctionOct 6, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "DURING THE IABC IMPLANTATION PROCEDURE, THE PUNCTURE WAS SUCCESSFULLY USED TO INSERT THE SHEATH TUBE AND THE GUIDE WIRE. WHEN CONNECTING THE CATHETER, THE CENTRAL LUMEN STUCK IN SHEATH. AFTER REPEATED ATTEMPTS, IT WAS UNSUCCESSFUL". 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 23220903 ↗
• MalfunctionSep 29, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "AFTER THE CATHETER WAS INSERTED, THE BLOOD WAS FOUND IN HELIUM PATHWAY". 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 23167385 ↗
• MalfunctionSep 26, 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 23154304 ↗
• MalfunctionSep 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS IMPLANTED THROUGH SURGERY. THE DOCTOR FEEDBACK THAT THE BALLOON HAD EXPANDED AFTER THE CATHETER WAS TAKEN OUT OF THE CATHETER PACKAGE AND THE CATHETER WAS IMPOSSIBLE TO PASS THROUGH THE PATIENT'S BODY AFTER INSERTING THE GUIDE WIRE. ADDITIONAL INFORMAITON 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 23143264 ↗
• MalfunctionSep 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PROCEDURE, THE BALLOON KINKED AND COULD NOT PASS THROUGH THE SHEATH". 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 23117747 ↗
• MalfunctionSep 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED "IT WAS FOUND THAT THE PUSH WAS DIFFICULT DURING THE IMPLANTATION PROCESS, . HOWEVER, THE SURGEON STILL MANAGED TO PLACE IT CORRECTLY. AFTER ACTIVATING THE PUMP, THE PUMP ALARMED HELIUM LEAKAGE. ATTEMPTS WERE MADE TO ADJUST THE POSITION OF THE BALLOON, BUT THE PUMP CONTINUED TO GIVE AN ALARM. CHANGE THE NEW CATHETER AND THE PUMP THEN OPERATED NORMALLY". ADDITIONAL INFORMATION STATES THAT THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085509 ↗
• MalfunctionSep 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED " THE BALLOON DAMAGED DURING THE USING". 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 23065950 ↗
• MalfunctionSep 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "WE EXPERIENCED AN INCIDENT WHERE A PATIENT ARRIVED FROM THE CATH LAB AND THE IABP ALARMED FOR HIGH PRESSURE AND HELIUM LOSS. AFTER TROUBLESHOOTING AND CHANGING THE CONSOLE, BLOOD WAS NOTED IN THE HELIUM TUBING, CONSISTENT WITH A BALLOON RUPTURE. THE IABP WAS REMOVED". ADDITIONAL INFORMAITON RECEIVED BY THE CUSTOMER STATES "THERE WAS NO HARM TO THE PATIENT. THE PATIENT ARRIVED TO THE CCU AFTER PLACEMENT IN THE LEFT FEMORAL ARTERY IN THE CATH LAB AND THERE WERE IMMEDIATELY ALARMS FOR HIGH PRESSURE AND HELIUM LOSS. BLOOD WAS NOTED IN THE HELIUM TUBING AT THAT TIME. THE IABP WAS REMOVED BY THE CARDIOLOGY FELLOW. THE FOLLOWING DAY 8/11 A SECOND IABP WAS PLACED IN THE LEFT FEMORAL ARTERY. THE PATIENT THEN WENT FOR CARDIAC SURGERY AS PLANNED AND IS NOW RECOVERING POST OPERATIVELY".

  Patient problems: Insufficient Information

  MAUDE report 23063259 ↗
• MalfunctionSep 15, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "A PATIENT WITH ACUTE MYOCARDIAL INFARCTION COMPLICATED WITH CARDIOGENIC SHOCK WAS TREATED WITH ECMO COMBINED WITH IABP. IN THE PROCESS OF INSERTION, THE CATHETER WAS STUCK IN SHEATH, 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 23057534 ↗
• MalfunctionSep 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY". 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 23006598 ↗
• MalfunctionSep 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY. THE PUMP IS NOT WORKING NORMALLY". ADDITIONAL INFORMAITON 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 22998901 ↗
• MalfunctionSep 4, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "USER WAS INITIATING THE IAB THERAPY FOR A PATIENT FOLLOWING INSTRUCTION OF USE, USER HAD COMBINE THE DILATOR WITH SHEATH AND LOCKED, THEN USER REMOVED THE DILATOR FROM SHEATH BUT FOUND THAT THE LUER LOCK HAD DISLODGED FROM THE DILATOR AND IT STILL LOCK WITH THE SHEATH. USER REMOVE THE ENTIRE ITEMS, AND USED ANOTHER ARROW 30CC IAB TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEM". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". AT THE TIME OF THIS REPORT, THE CUSTOMER HASNT RESPONDED TO OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22964334 ↗
• MalfunctionAug 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "DURING THE PROCESS OF PREPARING TO REMOVE THE CATHETER, IT WAS FOUND THAT THE CATHETER REMOVAL WAS DIFFICULT. AFTER A LONG PERIOD OF ATTEMPTS, THE CATHETER WAS FINALLY REMOVED FROM THE PATIENT'S BODY. UPON EXAMINATION, IT WAS VISUALLY OBSERVED THAT THERE WERE BLACK, UNIDENTIFIED SOLID PARTICLES GATHERED INSIDE THE BALLOON". THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22903170 ↗
• MalfunctionJul 28, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "THE CATHETER COULD NOT PASS THROUGH THE SHEATH AND THE SUPPORTING FORCE WAS INSUFFICIENT". 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 22630476 ↗

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-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-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-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-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-0969-2011 · Oct 11, 2010 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
• Z-0790-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
• Z-0792-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
• 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-1212-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the a

…and 12 more.