ARROW IPN000260Recalls & reported problems

Summary

The FDA's MAUDE database contains 698 adverse event reports that list this exact device (DI 00801902026804), received between Jul 19, 2018 and Sep 24, 2026 — classified as 4 deaths, 60 injuries, 634 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (138 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 698 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889530 ↗
• MalfunctionSep 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50763512 ↗
• MalfunctionSep 10, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719921 ↗
• MalfunctionSep 9, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697402 ↗
• MalfunctionSep 2, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50565864 ↗
• MalfunctionSep 1, 2026Entrapment of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548366 ↗
• InjuryAug 31, 2026Material Too Rigid or Stiff

  Patient problems: Vascular Dissection

  MAUDE report 50531314 ↗
• MalfunctionAug 31, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531098 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50530974 ↗
• InjuryAug 31, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50528859 ↗
• MalfunctionAug 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500911 ↗
• MalfunctionAug 28, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50499451 ↗
• MalfunctionAug 28, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498547 ↗
• MalfunctionAug 28, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50496367 ↗
• MalfunctionAug 26, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452949 ↗
• MalfunctionAug 25, 2026Difficult to Insert

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437707 ↗
• MalfunctionAug 19, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50327530 ↗
• MalfunctionNov 25, 2025Break; Break

  IT WAS REPORTED "IABC FOUND TO BE RUPTURE AFTER INSERTION WITHIN 30 MIN". ADDITIONAL INFORMATION STATES THAT THE IAB CATHER WAS REMOVED AND REPALCED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". 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 23645403 ↗
• MalfunctionNov 25, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INTO THE PATIENT, THE PUMP ALARMED HELIUM LOSS ALARM. AFTER THE BALLOON WAS WITHDRAWN, IT WAS FOUND THAT THE FRONT END OF THE BALLOON WAS FOLDING". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REPLACED INTO THE SAME 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 23644873 ↗
• MalfunctionNov 25, 2025Increase in Pressure; Increase in Pressure

  IT WAS REPORTED " THE CATHETER INSERTED INTO THE PATIENT SUCCESSFUL. AFTER ABOUT 3 MINUTES THE PUMP ALARMED THE BALLOON PRESSURE HIGH, AND THE COUNTERPULSATION WAS SUSPENDED. LATER, IT WAS DISCOVERED THAT THERE WAS BLOOD LEAKAGE, SO THE CATHETER WAS REMOVED. CHANGE THE NEW CATHETER". NO PATIENT'S INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644437 ↗
• MalfunctionNov 25, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INTO THE PATIENT, THE PUMP ALARMED HELIUM LOSS 2. AFTER THE CATHETER WAS REMOVED, IT WAS FOUND THAT THE FRONT END OF THE BALLOON WAS BENT". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REPLACED INTO THE SAME 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 23644330 ↗
• MalfunctionNov 25, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED "THE PEEL-AWAY HEMOSTASIS DEVICE COULD NOT BE REMOVED DURING USE. A NEW CATHETER WAS REPLACED AND REINSERTED". ADDITIONAL INFORMATION STATES THAT THE SECOND IAB CATHETER WAS INSERTED INTO THE SAME 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 23644232 ↗
• MalfunctionNov 24, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "DURING THE PROCESS OF IMPLANTING THE CATHETER INTO THE PATIENT, THE FRONT END OF THE BALLOON WAS BENT AND COULD NOT BE IMPLANTED INSIDE THE PATIENT'S BODY. AFTER REMOVAL, IT WAS FOUND THAT THE FRONT END OF THE BALLOON WAS BENT". 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 23633488 ↗
• MalfunctionNov 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BALLOON HAD NOT INFLATE COMPLETELY. THE BALLOON WAS FOUND RUPTURED AFTER REMOVE THE CATHETER. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENTS CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633171 ↗
• MalfunctionNov 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON NOT INFLATING IN BODY". 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 "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23632890 ↗

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-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-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-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-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-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-1211-2009 · Feb 2, 2009 · Terminated
  8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter

…and 12 more.