ARROW IPN915321Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10801902161939), received between Oct 1, 2022 and Feb 21, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

26 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.

Recalls naming this device

1. Apr 29, 2024Open, Classified

   Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.

   Z-1879-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

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.

• MalfunctionFeb 21, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, "AT ABOUT 10:00 ON (B)(6) 2023, IN THE CARDIAC SURGERY WARD, AFTER THE CATHETER WAS INSERTED INTO THE BODY, THE MACHINE GAVE AN ALARM AND THE BALLOON RUPTURE AFTER 2 DAY OF USE." THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16410241 ↗
• MalfunctionFeb 21, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON "(B)(6) 2023, THE PATIENT UNDERWENT EMERGENCY PCI UNDER DSA. AFTER THE OPERATION, THE BLOOD PRESSURE DROPPED. THE IABP CATHETER WAS INSERTED THROUGH THE RIGHT FEMORAL ARTERY, AND THE IABP WAS STARTED. UNDER DSA, IT WAS FOUND THAT THE BALLOON COULD NOT INFLATE NORMALLY. AFTER REPLACING THE NEW CATHETER, THE MACHINE WORKED NORMALLY AND THE PATIENT WAS TRANSFERRED TO THE WARD SMOOTHLY". THE 2ND IAB WAS INSERTED AT THE SAME INSERTION SITE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409909 ↗
• MalfunctionJan 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PUMP WAS STARTED AND PUMPED PROPERLY FOR APPROXIMATELY 3 MINUTES. THEN THERE WAS BLOOD FOUND IN THE HELIUM TUBE. THE BALLOON HAD RUPTURED. THE BALLOON CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED AT THE SAME INSERTION SITE. AFTER THE NEW BALLOON CATHETER WAS INSERTED, THE PUMP WAS RESTARTED AND BEGAN PUMPING NORMALLY. NO REPORT OF PATIENT HARM OR INJURY. PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114040 ↗
• MalfunctionDec 29, 2022Inflation Problem; Inflation Problem

  THE REPORT STATES THAT THE BALLOON DID NOT FULLY INFLATE UPON INSERTION. THEREFORE, A NEW BALLOON WAS INSERTED AT THE SAME INSERTION SITE. NO MEDICAL INTERVENTION WAS NEEDED. NO PATIENT INJURY OR CONSEQUENCE. PATIENT STATUS REPORTED AS "FINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068434 ↗
• MalfunctionNov 10, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "SHANGHAI FIRST PEOPLE'S HOSPITAL SONGJIANG BRANCH USED AN IABP CATHETER IN THE CATHETERIZATION LABORATORY. AFTER THE CATHETER WAS INSERT INTO A BLOOD VESSEL AND THE MACHINE WAS TURNED ON TO COUNTERPULSATE, THE DOCTOR NOTICED AN AIR LEAK IN THE MACHINE AND OBSERVED BLOOD IN THE HELIUM CONNECTION TUBE AT THE END OF THE CATHETER, THE DOCTOR JUDGED THAT THE BALLOON HAD RUPTURED AND THEN REMOVED THE CATHETER. A SECOND IAB WAS INSERTED AT THE SAME INSERTION SITE". THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15776462 ↗
• InjuryOct 26, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A 30CC ARROW IAB CATHETER CONNECTED TO MAQUET CARDIOSAVE IABP WAS PLACED IN THE PATIENT ON (B)(6) 2022 AT 1100, THE HELIUM DRIVELINE TUBING WAS DISCOVERED TO BE FILLED WITH BLOOD ON THE SAME DAY NIGHT AT 2330, AS MENTIONED BY THE USER. ALARM MESSAGE OF 'AUGMENTATION BELOW LIMIT SET' WAS ACTIVATED AS SHOWN ON THE PHOTOGRAPH PROVIDED. THE ALLEGED CATHETER WAS REMOVED AS A WHOLE WITH THE SHEATH FROM THE LEFT FEMORAL ARTERY AND REPLACED BY ANOTHER NEW 30CC IAB CATHETER WHICH WAS INSERTED FROM THE RIGHT SIDE FEMORAL. NO SIGNIFICANT OBSERVABLE DAMAGE ON THE CATHETER AND THE BALLOON WHEN IT WAS RETURNED BY THE SALES REPRESENTATIVE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15673735 ↗
• MalfunctionOct 1, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT AFTER THE CATHETER WAS IMPLANTED DURING THE OPERATION, THE BALLOON CATHETER WAS FOUND RUPTURED. AS A RESULT, A NEW IAB WAS INSERTED AT THE SAME INSERTION SITE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS, SERIOUS INJURY OR DEATH. THERE ARE NO AVAILABLE PHOTOGRAPHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15523090 ↗

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-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-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-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-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-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-0969-2011 · Oct 11, 2010 · Terminated
  Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters Model: IAK-05845
• Z-0792-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Sheath, Ultra 8 Fr, 30cc. Model: IAB-05830-LWS
• Z-0790-2011 · Oct 11, 2010 · Terminated
  Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. Model: IAB-05830-U
• Z-0793-2011 · Oct 11, 2010 · Terminated
  FiberOptix IAB Ultra 8 Fr, 40cc Model: IAB-05840-LWS
• Z-1215-2009 · Feb 2, 2009 · Terminated
  7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in t
• 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 11 more.