ARROW IPN038074Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801902136701), received between Dec 5, 2022 and Aug 16, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT "DURING THE OPERATION, THE BALLOON WAS FOUND KINKED." AS A RESULT, THE IAB WAS REMOVED AND 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 17557112 ↗
• MalfunctionAug 8, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER PLACEMENT OF THE CATHETER, THERE WAS NO PROBLEM AT FIRST. HOWEVER, THE BALLOON GOT RUPTURED AND BLOOD WAS NOTED IN HELIUM DRIVELINE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE USER, THE RUPTURE MIGHT HAVE BEEN CAUSED BY CALCIFICATION OF THE PATIENT'S AORTA." ADDITIONAL INFORMATION STATES THAT "THE INITIAL CATHETER WAS INSERTED FROM THE GROIN, AND THE SECOND CATHETER WAS INSERTED FROM THE CONTRALATERAL GROIN". FURTHERMORE, "BLOOD WAS NOTED IN THE HELIUM DRIVELINE OF THE 2ND CATHETER. AS A RESULT, THE 2ND CATHETER WAS REMOVED AND REPLACED WITH 3RD ONE. BUT BLOOD WAS NOTED IN HELIUM DRIVELINE OF 3RD CATHETER. THE 3RD CATHETER WAS REMOVED. A NEW CATHETER WASN'T REPLACED. THE PATIENT WAS UNDER FOLLOW-UP IN THE CCU. THE BALLOONS GOT RUPTURED IN ALL THREE CATHETERS." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS #3010532612-2023-00443 AND #3010532612-2023-00409.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482219 ↗
• MalfunctionAug 8, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER PLACEMENT OF THE CATHETER, THERE WAS NO PROBLEM AT FIRST. HOWEVER, THE BALLOON GOT RUPTURED AND BLOOD WAS NOTED IN HELIUM DRIVELINE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE USER, THE RUPTURE MIGHT HAVE BEEN CAUSED BY CALCIFICATION OF THE PATIENT'S AORTA." ADDITIONAL INFORMATION STATES THAT "THE INITIAL CATHETER WAS INSERTED FROM THE GROIN, AND THE SECOND CATHETER WAS INSERTED FROM THE CONTRALATERAL GROIN". FURTHERMORE, "BLOOD WAS NOTED IN THE HELIUM DRIVELINE OF THE 2ND CATHETER. AS A RESULT, THE 2ND CATHETER WAS REMOVED AND REPLACED WITH 3RD ONE. BUT BLOOD WAS NOTED IN HELIUM DRIVELINE OF 3RD CATHETER. THE 3RD CATHETER WAS REMOVED. A NEW CATHETER WASN'T REPLACED. THE PATIENT WAS UNDER FOLLOW-UP IN THE CCU. THE BALLOONS GOT RUPTURED IN ALL THREE CATHETERS." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS #3010532612-2023-00409 AND #3010532612-2023-00444.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482218 ↗
• InjuryAug 8, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "AFTER PLACEMENT OF THE CATHETER, THERE WAS NO PROBLEM AT FIRST. HOWEVER, THE BALLOON GOT RUPTURED AND BLOOD WAS NOTED IN HELIUM DRIVELINE. THEREFORE, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. NO INJURY TO THE PATIENT WAS REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. ACCORDING TO THE USER, THE RUPTURE MIGHT HAVE BEEN CAUSED BY CALCIFICATION OF THE PATIENT'S AORTA." ADDITIONAL INFORMATION STATES THAT "THE INITIAL CATHETER WAS INSERTED FROM THE GROIN, AND THE SECOND CATHETER WAS INSERTED FROM THE CONTRALATERAL GROIN". FURTHERMORE, "BLOOD WAS NOTED IN THE HELIUM DRIVELINE OF THE 2ND CATHETER. AS A RESULT, THE 2ND CATHETER WAS REMOVED AND REPLACED WITH 3RD ONE. BUT BLOOD WAS NOTED IN HELIUM DRIVELINE OF 3RD CATHETER. THE 3RD CATHETER WAS REMOVED. A NEW CATHETER WASN'T REPLACED. THE PATIENT WAS UNDER FOLLOW-UP IN THE CCU. THE BALLOONS GOT RUPTURED IN ALL THREE CATHETERS." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE". SEE ASSOCIATED MDRS#: 3010532612-2023-00443 AND #: 3010532612-2023-00444.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482214 ↗
• MalfunctionMay 25, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE BALLOON WAS FOUND TO BE RUPTURED. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT THE SAME INSERTIONS SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002749 ↗
• MalfunctionFeb 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "AFTER INSERTION, THE PUMP WAS STARTED AND BLOOD WAS FOUND IN THE HELIUM TUBE. THE DOCTOR STOPPED THE MACHINE IMMEDIATELY AND REMOVED THE CATHETER. THE CENTRAL CAVITY WAS FOUND BROKEN". ADDITIONAL INFORMATION STATES THAT ANOTHER IAB WAS NOT INSERTED. NO HARM OR INJURY TO THE PATIENT. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 16435591 ↗
• MalfunctionDec 5, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE USER INSERTED THE SHEATH FROM THE FEMORAL AND DELIVERED THE CATHETER TO THE DESIRED POSITION. THEN ATTEMPTED TO BEGIN PUMPING, BUT THE BALLOON DID NOT INFLATE. THEREFORE, THE CATHETER WAS PROMPTLY REMOVED AND REPLACED IN THE SAME SITE WITH A NEW ONE, WITH WHICH THE IABP WORKED NORMALLY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15920670 ↗

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-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-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-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-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-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.