ARROW IPN039793Recalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 10801902145748), received between Dec 17, 2025 and Apr 17, 2026 — classified as 62 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (11 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Difficult to Remove

  IT WAS REPORTED ", THE CATHETER WAS DIFFICULT TO REMOVE, SOME BLADDER MEMBRANE ARE STILL WITHIN THE VESSEL LUMEN". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED IN ITS ENTIRETY AND NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24912310 ↗
• MalfunctionApr 16, 2026Inflation 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 24895676 ↗
• MalfunctionApr 9, 2026Difficult to Open or Remove Packaging Material

  IT WAS REPORTED "DURING THE CATHETER INSERTION PROCEDURE, THE BALLOON STUCK IN SHEATH. 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 24829403 ↗
• MalfunctionApr 9, 2026Device Alarm System

  IT WAS REPORTED "THE CATHETER INSERTED INTO THE PATIENT SUCCESSFULLY. AFTER 10 MINUTES, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. RECONNECTING THE TUBING, ADJUSTING THE BALLOON POSITION, THE ISSUE STILL COULD NOT BE RESOLVED. 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 24829259 ↗
• MalfunctionApr 7, 2026Material Rupture

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE CENTRAL LUMEN RUPTURED. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUNECE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24805897 ↗
• MalfunctionApr 6, 2026Inflation Problem

  IT WAS REPORTED ", THE CATHETER WAS SUCCESSFULLY INSERTED. DSA REVEALED THAT THE DISTAL END OF THE BALLOON FAILED TO INFLATE. DOCTOR USED A SYRINGE FROM THE CLINICAL KIT TO INFLATE THE BALLOON, WHICH LED TO SLIGHT IMPROVEMENT, BUT THE DISTAL SEGMENT REMAINED UN-INFLATED. THE IABP FUNCTIONED NORMALLY WITH NO ALARMS. THE PATIENT WAS TRANSFERRED TO THE ICU. AFTER APPROXIMATELY 2 HOURS OF OPERATION, AN ALARM WAS TRIGGERED: BALLOON PRESSURE TOO HIGH. DOCTOR ADJUSTED THE VOLUME TO 30CC AND CONTINUED SUPPORT. THE PATIENT HAS NOT BEEN WEANED FROM THE IABP, AND NO FURTHER ALARMS HAVE OCCURRED". 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 24789008 ↗
• MalfunctionApr 2, 2026Inflation Problem

  IT WAS REPORTED "AFTER THE CATHETER INSERTED, THE BALLOON CAN NOT INFLATE COMPLETELY, CHANGE THE NEW CATHETER". 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 24767783 ↗
• MalfunctionMar 31, 2026Fracture

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, IABP CONTINUOUS ALARMED HELIUM LEAKAGE. UPON THE CATHETER REMOVAL, A FRACTURE WAS FOUND AT THE TIP OF THE BALLOON'S 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 24741987 ↗
• MalfunctionMar 30, 2026Material Deformation

  IT WAS REPORTED ", AFTER THE CATHETER INSERTED INTO THE PATIENT, THE BLOOD WAS FOUND IN THE HELIUM PATHWAY AND CENTRAL LUMEN WAS FOUND DAMAGED AFTER THE CATHETER REMOVAL". 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 24728374 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak

  IT WAS REPORTED "ON (B)(6), THE CATHETER WAS SUCCESSFULLY INSERTED INTO THE PATIENT. THE DEVICE FUNCTIONED NORMALLY POST-IMPL ANTATION, WITH NO ABNORMALITIES DETECTED DURING ROUTINE CHECKS, AND THE PATIENT'S CIRCULATION GRADUALLY STABILIZED. ON (B)(6), APPROXIMATELY 100ML OF OOZING BLOOD WAS OBSERVED AT THE CATHETER INSERTION SITE, AND THE BALLOON RUPTURE WAS IDENTIFIED. THE CATHETER WAS REMOVED". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24700133 ↗
• MalfunctionMar 25, 2026Material Integrity Problem

  IT WAS REPORTED "IABP BALLOON INSERTED INTO PATIENT; CONNECTED TO GENTIGE IABP MACHINE, ABLE TO START AUGMENTATION INITIALLY. IABP MACHINE ALERT: CIRCUIT LEAK. EXTERNAL CIRCUIT CHECKED, CONNECTIONS SECURE, NO OBVIOUS LEAK. UNABLE TO AUGMENT. NOTICED BLOOD IN HELIUM LUMEN, SUGGESTIVE OF BREACH BETWEEN HELIUM LUMEN AND BLOOD LUMEN. IABP BALLOON IMMEDIATELY REMOVED FROM PATIENT". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 24689932 ↗
• MalfunctionMar 25, 2026Inflation Problem

  IT WAS REPORTED "'FAILURE OF THE INTRA-AORTIC BALLOON TO COMPLETELY INFLATE OVER ITS FULL LENGTH'. IABP ATTEMPTED TO BE TAKEN OUT WITHSHEATH LEFT IN INITIALLY, NOTED BALLOON WAS BROKEN AND TOOK OUT WITH SHEATH ALTOGETHER. IAB REMOVED IN OT. ATTEMPT MADE TO REMOVE THROUGH SHEATH. IAB WIRED SNAPPED IN PROCESS (SINGLE POINT BREAK).IAB AND SHEATH REMOVED TOGETHER. IDENTIFIED IAB NOT INFLATING AT TOP AND REMOVED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". PLEASE SEE ASSOCIATED MDR#: 3010532612-2026-00265.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689915 ↗
• MalfunctionMar 24, 2026Material Integrity Problem

  IT WAS REPORTED ", THE IABP ALARMED, AND THE BALLOON WAVEFORM INDICATED CATHETER KINKING. EXAMINATION REVEALED THAT THE HEMOSTASIS CUFF HAD DETACHED FROM THE HEMOSTASIS SHEATH INTRODUCER. THE EXPOSED SHAFT WAS CONTAMINATED AND COULD NOT BE REINSERTED INTO THE PATIENT. THE CATHETER WAS REPLACED WITH A NEW SET, AND ASSISTANCE FOR THE PATIENT WAS CONTINUED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24681258 ↗
• MalfunctionMar 12, 2026Material Integrity 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 CONDITIOIN IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24580812 ↗
• MalfunctionMar 11, 2026Material Twisted/Bent

  IT WAS REPORTED "THE BALLOON BENT WHEN INSERTED INTO THE PATIENT AND COULD NOT BE DELIVERED TO THE AORTA. 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 24570416 ↗
• MalfunctionMar 10, 2026Leak/Splash

  IT WAS REPORTED "DURING THE CATHETER WAS INSERTED INTO THE PATIENT, THE BALLOON RUPTURED. 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 24559528 ↗
• MalfunctionMar 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. THE IABC BALLOON RUPTURED AND BLOOD IN HELIUM PATHWAY. A NEW BALLOON WAS REPLACED AND IS NOW FUNCTIONING 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 24558396 ↗
• MalfunctionMar 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED "BALLOON RUPTURED WHEN USER OBSERVER HAD BLOOD IN THE HELIUM TUBING". 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 "STABLE".

  Patient problems: Insufficient Information

  MAUDE report 24518624 ↗
• MalfunctionMar 4, 2026Fluid/Blood Leak

  IT WAS REPORTED ", THE CATHETER WAS INSERTED INTO THE PATIENT AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AFTER THE SURGERY. THE BALLOON WAS FOUND LEAKAGE". ADDITIONAL INFORMATION 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 24512206 ↗
• MalfunctionFeb 24, 2026Material Twisted/Bent

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE 2. AFTER REMOVE THE CATHETER, THE END OF BALLOON IS BENT. 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 24433275 ↗
• MalfunctionFeb 24, 2026Break

  IT WAS REPORTED "DURING A ROUTINE WARD INSPECTION, THE PATIENT WAS OBSERVED CHANGING POSITION INDEPENDENTLY. THE CATHETER WAS DISINFECTED, AND THE EXTERNAL PORTION WAS ADJUSTED APPROPRIATELY. THE PATIENT WAS INSTRUCTED TO STRICTLY IMMOBILIZE THE LOWER LIMBS. AT APPROXIMATELY 15:58, A SMALL AMOUNT OF PINK FROTHY FLUID WAS NOTED IN THE IABP INFLATION TUBING, RAISING SUSPICION OF POSSIBLE BALLOON RUPTURE. AT 17:50, WITH COORDINATED EFFORTS FROM THE MEDICAL STAFF, THE IABP BALLOON WAS REMOVED. THE PATIENT REPORTED NO DISCOMFORT FOLLOWING THE PROCEDURE. THE PUNCTURE SITE ON THE RIGHT LOWER LIMB WAS BANDAGED WITH PRESSURE. CURRENTLY, THE PATIENT'S HEART RATE IS 75 BEATS PER MINUTE, AND BLOOD PRESSURE IS 118/78 MMHG. CLOSE MONITORING IS ONGOING". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429652 ↗
• MalfunctionFeb 24, 2026Material Twisted/Bent

  IT WAS REPORTED " AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP ALARMED HELIUM LEAKAGE 3. AFTER REMOVE THE CATHETER, THE FRONT OF BALLOON IS BENT. CHANGE THE NEW CATHETER". NO PATIENT INJURY OR CONSEQUNECE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428178 ↗
• MalfunctionFeb 23, 2026Material Rupture

  IT WAS REPORTED "AFTER THE CATHETER INTO THE PATIENT, WHEN STARTING THE IABP, THE BALLOON RUPTURED. 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 24413653 ↗
• MalfunctionFeb 17, 2026Device Alarm System

  IT WAS REPORTED "AFTER THE SURGERY IS COMPLETED, THE PUMP REPORTED THE HELIUM LOSS ALARM. REMOVE THE CATHETER". ADDITIONAL INFO STATES THAT THE IAB CATHETER WAS 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 24365321 ↗
• MalfunctionFeb 17, 2026Inflation 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 24365097 ↗

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-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-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-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-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-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-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-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-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-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-0793-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-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-1216-2009 · Feb 2, 2009 · Terminated
  8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in

…and 12 more.