ARROW IPN039778Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10801902145618), received between Oct 12, 2022 and Apr 22, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Obstruction of Flow

  IT WAS REPORTED THAT "THE GUIDEWIRE WAS SUCCESSFULLY PLACED, BUT IT WAS FOUND THAT THE BALLOON COULD NOT BE DEPLOYED FROM THE SHEATH. DESPITE REPEATED ATTEMPTS, IT WAS UNSUCCESSFUL. WHEN PLANNING TO REMOVE AND REPLACE THE BALLOON, IT WAS FOUND THAT THE BALLOON COULD NOT BE WITHDRAWN. DURING THE ATTEMPT, AN ABNORMAL BALLOON CONDITION WAS OBSERVED UNDER DSA. AFTER REMOVAL, IT WAS FOUND THAT THE CENTRAL LUMEN WAS FRACTURED". THE CATHETER WAS NOT REPLACED. NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956527 ↗
• MalfunctionApr 22, 2026Device Alarm System

  IT WAS REPORTED THAT "(B)(6) 2026, THE CATHETER WAS INSERTED INTO THE PATIENT SUCCESSFULLY. ON (B)(6) 2026, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. CHANGE THE CATHETER". THE NEW CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955052 ↗
• MalfunctionApr 9, 2026Material Rupture

  IT WAS REPORTED " THE PUMP REPEATEDLY REPORTED HELIUM LEAKS. AT 8 AM, THE NURSE FOUND BLOOD IN HELIUM PATHWAY, WITHDREW THE PUMP, REMOVED THE CATHETER, AND DISCOVERED BALLOON RUPTURE, BLOOD ENTERING THE MACHINE'S INTERNAL PIPELINE". ADDITIONAL INFORMATION STATES THAT AFTER THE DEVICE WAS REMOVED, IT WAS NOT REPLACED. NO PATIENT INJURY OR COSNEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS RPEORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831493 ↗
• MalfunctionApr 9, 2026Device Alarm System

  IT WAS REPORTED "AFTER THE CATHETER INSERTED INTO THE PATIENT, THE PUMP TRIGGERED A HELIUM LEAKAGE ALARM. REMOVE THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 24829318 ↗
• MalfunctionMar 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED "THE CATHETER WAS INSERTED INTO THE PATIENT. AT 16:00 ON (B)(6) 2025, THE PUMP CONTINUOUSLY ALARMED; THROMBI WERE OBSERVED INSIDE THE BALLOON, RAISING SUSPICION OF BALLOON 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 24730518 ↗
• MalfunctionMar 27, 2023Break; Break

  IT WAS REPORTED THAT THE IAB WAS FOUND BROKEN. AS A RESULT, A 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618973 ↗
• MalfunctionMar 14, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE KINKED DURING USE ON A PATIENT. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537035 ↗
• MalfunctionDec 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "THE IAB WAS INSERTED INTO THE FEMORAL ARTERY (UNKNOWN IF RIGHT OR LEFT SIDE) AND ADVANCED TO INTENDED AREA. THEN, THE PUMPING STARTED BUT THE BALLOON RUPTURED. AS A RESULT, THE IAB WAS REMOVED AND THE SAME SIZED IAB CATHETER (IAB-06830-U) WAS INSERTED AT THE SAME INSERTION SITE". PATIENT CONDITION REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893669 ↗
• MalfunctionNov 10, 2022Leak/Splash; Leak/Splash

  AS REPORTED BY A TELEFLEX CLINICAL SUPPORT SPECIALIST, "POSSIBLE IAB RUPTURE, NO BLOOD IN TUBING. FREQUENT ALARMS ON THE MAQUET PUMP. ALL OF THE CONNECTIONS WERE DOUBLE CHECKED AND TIGHT. A SECOND DRIVE LINE WAS ATTACHED, AND ALARMS CONTINUED. IAB WILL BE REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE". THE SECONDARY IAB WAS INSERTED AT THE SAME INSERTION SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771943 ↗
• MalfunctionNov 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED". ADDITIONAL INFORMATION STATES THAT THE SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734639 ↗
• MalfunctionNov 4, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER 3 MINUTES OF USE, THE MACHINE FREQUENTLY ALARMED FOR HELIUM LOSS. THE ISSUE COULD NOT BE RESOLVED BY ADJUSTING THE EQUIPMENT AND THE CATHETER. AS A RESULT, THE CATHETER WAS REPLACED, AND THE PROBLEM WAS SOLVED". ADDITIONAL INFORMATION STATES THAT THE SECONDARY CATHETER WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15732582 ↗
• InjuryNov 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE REPORT STATES THAT "THE MACHINE ALARMED AND FOUND THAT BLOOD APPEARED IN THE HELIUM TUBE, AND [THE PHYSICIAN] WITHDREW THE CATHETER. [THE PHYSICIAN] RINSED THE REMOVED CATHETER, AND AFTER FLUSHING, IT WAS FOUND THAT THE CENTRAL CAVITY WAS RUPTURED. AS A RESULT, A SECOND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE". PATIENT STATUS WAS "CRITICAL" PRIOR TO EVENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15721955 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "A 30CC ARROW IAB CATHETER CONNECTED TO MAQUET CARDIOSAVE IABP WAS PLACED IN THE PATIENT ON (B)(6) 2022 AT 1400, THE HELIUM DRIVELINE TUBING WAS DISCOVERED TO BE FILLED WITH BLOOD ON (B)(6) 2022 MORNING, AS MENTIONED BY THE [CUSTOMER]. THEN, THE 30CC IAB CATHETER AND SHEATH WERE REMOVED AS A WHOLE FROM THE PATIENT AND EXCHANGED FOR A NEW SET OF ARROW ULTRAFLEX 30CC IAB CATHETER". FURTHER ADDITIONAL INFORMATION STATES THAT THE "[CUSTOMER] CONFIRMED THAT THERE WAS NO REPLACEMENT OF THE ALLEGED IAB CATHETER INTO THE PATIENT AS THE PATIENT WAS FINE WITHOUT IAB SUPPORT. THE [PHYSICIAN] ALSO STATED THAT THE INSERTION OF THE [ORIGINAL] IAB CATHETER WAS SMOOTH". NO REPORT OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625292 ↗
• MalfunctionOct 18, 2022Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  THE REPORT STATES THAT "THE BALLOON RUPTURED DURING USE ON THE PATIENT. AS A RESULT, A NEW IAB WAS USED AND INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625150 ↗
• MalfunctionOct 13, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT "ON THE MORNING OF (B)(6), 2022, A [CLINICIAN] FROM THE CCU OF HENAN PROVINCIAL PEOPLE'S HOSPITAL, INSERTED THE IAB-06830-U CATHETER FOR THE PATIENT. AFTER THE CATHETER WAS INSERTED, [THE CLINICIAN] FOUND THAT THERE WAS A CRACK ON THE AIRCRAFT SHEATH ATTACHED TO THE TAIL OF THE CATHETER, AND BLOOD WAS LEAKING OUT ALONG THE CRACK. AFTER MANY ATTEMPTS OF [COMPRESSION], THE PROBLEM WAS STILL NOT SOLVED. THE [CLINICIAN] PLANNED TO PULL OUT THE CATHETER AND PUNCTURE WITH SHEATH. THE [CLINICIAN] INSERTED WITH A NEW SET OF IAB CATHETERS." ADDITIONAL INFORMATION STATES THAT "IT WAS A SHEATHLESS INSERTION. NO DEFECT PRIOR TO THE INSERTION. THE CRACK IS PEEL-AWAY HEMOSTASIS DEVICE". FURTHER INFORMATION STATES THAT AN ADDITIONAL CATHETER WAS INSERTED AT A SECOND INSERTION SITE OF THE RIGHT FEMORAL ARTERY AND THAT THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15594945 ↗
• MalfunctionOct 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT "ON THE MORNING OF (B)(6) 2022, A [CLINICIAN] FROM THE CCU OF HENAN PROVINCIAL PEOPLE'S HOSPITAL, INSERTED THE IAB-06830-U CATHETER FOR THE PATIENT. AFTER THE CATHETER WAS INSERTED, [THE CLINICIAN] FOUND THAT THERE WAS A CRACK ON THE AIRCRAFT SHEATH ATTACHED TO THE TAIL OF THE CATHETER, AND BLOOD WAS LEAKING OUT ALONG THE CRACK. AFTER MANY ATTEMPTS OF [COMPRESSION], THE PROBLEM WAS STILL NOT SOLVED. THE [CLINICIAN] PLANNED TO PULL OUT THE CATHETER AND PUNCTURE WITH SHEATH. THE [CLINICIAN] INSERTED WITH A NEW SET OF IAB CATHETERS." ADDITIONAL INFORMATION STATES THAT "IT WAS A SHEATHLESS INSERTION. NO DEFECT PRIOR TO THE INSERTION. THE CRACK IS PEEL-AWAY HEMOSTASIS DEVICE". FURTHER INFORMATION STATES THAT AN ADDITIONAL CATHETER WAS INSERTED AT A SECOND INSERTION SITE OF THE RIGHT FEMORAL ARTERY AND THAT THERE WAS NO HARM OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591420 ↗

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-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-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-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-0791-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. Model: IAB-05840-U
• 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-0969-2011 · Oct 11, 2010 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
• Z-1217-2009 · Feb 2, 2009 · Terminated
  8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in

…and 12 more.