ARROW IPN038075Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801902136695), received between Mar 14, 2023 and Aug 8, 2024 — classified as 4 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024

  AFTER NON COMPLICATED IABP (INTRA-AORTIC BALLOON PUMP) INSERTION, THE BALLOON WAS VIEWED UNDER FLUOROSCOPY AND FOUND TO ONLY PARTIALLY INFLATE. THE DISTAL PART OF THE BALLOON DID NOT UNWIND, AND THEREFORE DID NOT INFLATE. BECAUSE OF THIS MALFUNCTION, THE IABP MACHINE WOULD NOT FUNCTION DUE TO A HIGH-PRESSURE WARNING. THE DEFECTIVE BALLOON WAS REMOVED, AND AFTER FURTHER CLINICAL EVALUATION, PROVIDER DECIDED NOT TO REPLACE IT. MANUFACTURER RESPONSE FOR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL, ARROW (PER SITE REPORTER) UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937471 ↗
• MalfunctionJan 12, 2024

  THE IMPLANTED 40CC IAB CATHETER RUPTURED, REQUIRING THAT THE PATIENT BE PUT BACK ON THE TABLE, THE EXISTING IAB BE REMOVED AND A NEW ONE BE IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 18502094 ↗
• MalfunctionAug 22, 2023

  AFTER INSERTION OF A 40CC INTRAAORTIC BALLOON (IAB) IN THE PATIENT, WHILE SUTURING THE IAB IN PLACE, BLOOD WAS NOTED IN THE HELIUM SUPPLY LINE AND THE LOSS OF HELIUM ALARM WENT OFF. THE IAB WAS TURNED OFF AND UNDER FLUOROSCOPY THE SHAFT OF THE IAB WAS NOTED TO BE FRACTURED. THE IAB AND ITS SHEATH WERE REMOVED AND REPLACED WITH A NEW 40CC IAB AND 9 FR. BRITE TIP SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17595025 ↗
• InjuryAug 14, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "[THE DOCTOR] FOUND THE CATHETER LEAK DURING USED ON THE PATIENT". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT A DIFFERENT INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541155 ↗
• MalfunctionAug 10, 2023Inflation Problem; Inflation Problem

  THE REPORT STATES, "PROBLEMS WITH SHUTTLING OF THE HELIUM WAS NOTICED IMMEDIATELY (BALLOON WAVEFORM) AND TROUBLESHOOTING WAS DONE FOR 30 MINUTES. PATIENT DID NOT HAVE AN TORTUOUS AORTA NOR WAS THE PATIENT OBESE. INITIALLY THE BALLOON DID NOT UNFURL COMPLETELY AND WAS EXPANDED WITH A SYRINGE IN THE USUAL MANNER. NO KINK WAS SEEN IN THE LINE WHEN EXAMINED UNDER FLUOROSCOPY. THE PROBLEM WAS SORTED WITH READJUSTMENT OF THE CATHETER AND SHEATH. ON (B)(6) 2023 DURING A ROUTINE CHECK IT WAS NOTICED THAT THE GAS WAS NOT SHUTTLING BACK (SLOW DEFLATION) CORRECTLY AND THE CATHETER WAVEFORM WAS ABNORMAL. AT THIS POINT THE CONSOLE STARTED ALARMING. WE IMMEDIATELY REMOVED THE CATHETER FROM THE PATIENT. ERRORS SEEN WERE: GAS LOSS ALARM AND GAS GAIN ALARM". NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "STABLE". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17503555 ↗
• MalfunctionAug 8, 2023Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE IAB RUPTURED. 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 17481863 ↗
• MalfunctionJul 12, 2023Leak/Splash; Material Protrusion/Extrusion; Leak/Splash; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE BALLOON WOULD NOT COMPLETELY INFLATE. AS A RESULT, THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 17312380 ↗
• MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH, "CONCERN FOR BLOOD BACKING INTO THE IABP (INTRA-AORTIC BALLOON PUMP) TUBING AND CONCERN FOR PERFORATION". 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: Insufficient Information

  MAUDE report 17088463 ↗
• InjuryMay 17, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AFTER THE CATHETER WAS INSERTED, THE BALLOON WOULD NOT INFLATE. AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND CATHETER WAS INSERTED AT A DIFFERENT INSERTION SITE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16948034 ↗
• InjuryApr 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT AN IAB WAS INSERTED IN THE RIGHT FEMORAL IN THE CATH LAB. THE PLACEMENT WAS VERIFIED VIA FLUOROSCOPY, WAS SUTURED IN PLACE, AND A STATLOCK ADDED FOR FURTHER SECUREMENT. THE NEXT DAY IN THE CCU, THE IAB WAS NOTED TO STILL BE SECURELY SUTURED IN AT THE APPROPRIATE POINTS AND STATLOCK REMAINED IN PLACE. IT WAS NOTED THAT THE DISTAL END OF THE CATH-GUARD CONTAMINATION SHIELD HAD COME UNSEALED DUE TO AN UNKNOWN CAUSE". AS A RESULT, THE CATHETER WAS REMOVED AND A 2ND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE, IN THE LEFT FEMORAL. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: Needle Stick/Puncture

  MAUDE report 16799544 ↗
• InjuryMar 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN IAB WAS INSERTED INTO THE RIGHT FEMORAL ARTERY. BLOOD WAS THEN FOUND IN THE HELIUM TUBE AFTER INSERTION. THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED AT A DIFFERENT INSERTION SITE AT THE LEFT FEMORAL ARTERY. THE PATIENT STATUS IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554110 ↗
• MalfunctionMar 14, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  REPORTED AS "SHEATH DILATOR SPLIT AT TIP". THE REPORT STATES "COULD NOT GET INTRODUCER TO PENETRATE THROUGH SKIN. WHEN THE DOCTOR PULLED BACK HE NOTICED THE BLUE DILATOR WAS SPLIT AT THE TIP." AS A RESULT, ANOTHER IAB WAS USED AND INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16539383 ↗

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-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-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-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-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-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-1222-2009 · Feb 2, 2009 · Terminated
  ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation

…and 12 more.