ARROW IPN038264Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10801902144192), received between Aug 10, 2022 and Nov 25, 2025 — classified as 6 injuries, 102 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (62 reports).

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

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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED "CATHETER PLACED FOR EP PROCEDURE AND WHEN THEY TRIED TO REMOVE THROUGH THE BALLOON NOTED TO BE "WRAPPED" UP AT THE DISTAL END WHICH HAD NOT HAPPENED BEFORE. UPON QUESTIONING THE BALLOON WAS ATTEMPTED TO BE REMOVED FROM THROUGH THE SHEATH. NO ISSUES OR ALARMS WERE REPORTED DURING IABP USE ON THE PATIENT". 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 23645648 ↗
• MalfunctionNov 12, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED "CONSISTENT POSSIBLE HELIUM LOSS ALARMS". 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 "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 23531973 ↗
• MalfunctionSep 5, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "BALLOON WAS INSERTED AND CONNECTED TO THE CONSOLE AND PUMPING WAS INITIATED. UNDER FLUOROSCOPY THE BALLOON INFLATION WAS SEEN BUT NO DEFLATION WAS VISUALIZED. AFTER 30 SEC TO 1MIN THE CONSOLE ERRORED AS LEAK DETECTED BUT THERE WERE NO KINKS OR BREAKS IDENTIFIED AND ALL CONNECTIONS WERE SECURE. MANUAL DEFLATION WAS PERFORMED AND BALLOON WAS REMOVED AND ENTIRE SYSTEM EXCHANGED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22979530 ↗
• MalfunctionJun 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " BALLOON FAILED TO UNWRAP". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE" PLEASE SEE ASSOCIATED MDR#: 3010532612-2025-00535.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205963 ↗
• MalfunctionJun 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED " BALLOON FAILED TO UNWRAP". ADDITIONAL INFORMATION STATES THE IAB CATHETER WAS REMOVED AND REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE" PLEASE SEE ASSOCIATED MDR#: 3010532612-2025-00536.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205951 ↗
• MalfunctionApr 9, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED "UNABLE TO VISUALIZE CATHETER AFTER PLACEMENT". ADDITIONAL INFORMATION RECEIVED STATES THE IAB CATHETER WAS REMOVED AND REPLACED. THERE WERE NO ISSUES WITH THE SECOND IAB CATHTER. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21808860 ↗
• MalfunctionFeb 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "FAILURE TO UNWRAP".ADDITIONAL INFORMATION STATES THAT THE CATHETER WAS REMOVED AND REPLACED TO CONTINUE THERAPY. THE SECOND IAB CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 21469150 ↗
• MalfunctionJan 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED "IAB RUPTURE". ADDITIONAL INFORMATION STATES THAT THE CATHETER WAS REMOVED AND REPLACED TO CONTINUE THERAPY. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 21199593 ↗
• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED "BALLOON FAILED TO INFLATE". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY, ANOTHER IAB CATHETER WAS INSERTED. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 21124942 ↗
• MalfunctionJan 10, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED "BALLOON FAILED TO INFLATE". ADDITIONAL INFORMATION STATES THAT A SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE WAS REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123483 ↗
• MalfunctionDec 27, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED "BALLOON RUPTURE". ADDITIONAL INFORMATION STATED THAT THE CATHETER WAS REMOVED AND NOT REPLACED. THE CUSTOMER REPORTED NO HARM TO THE PATIENT. NO OTHER DETAILS FROM THE CUSTOMER HAVE BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21026432 ↗
• MalfunctionDec 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "SUSPECTED FAILURE TO UNWRAP". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED AND NOT REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 20968760 ↗
• MalfunctionDec 16, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED "OVER TWISTED BALLOON WRAP". NO PATIENT INVOLVEMENT REPORTED. THIS ISSUE IS REPORTED HAPPENING PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20944983 ↗
• MalfunctionDec 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "RUPTURED ARROW BALLOON". ADDITIONAL INFORMATION STATES THAT THE IAB CATHETER WAS REMOVED. IT IS UNKNOWN IF THE IAB CATHETER WAS REPLACED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833256 ↗
• MalfunctionNov 4, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT: "IAB FAILED TO UNWRAP". ADDITIONAL INFORMATION: "THE CUSTOMER CALLED TO REPORT AN IAB THAT IS NOT UNWRAPPING AT DISTAL END. THEY FIRST RECEIVED HIGH PRESSURE ALARMS FROM THE IABP. ON FLUORO, DISTAL TIP WAS VISUALIZED TO NOT BE UNWRAPPING. THEY ATTEMPTED MANUAL INFLATION TWICE AND CONFIRMED IAB TIP IS BETWEEN 2ND AND 3RD INTERCOSTAL. NO CHANGE AFTER MANUAL INFLATIONS. RECOMMENDED REMOVAL OF IAB. PATIENT REMAINED STABLE. ANOTHER DEVICE WAS INSERTED INTO THE SAME ACCESS SITE WITHOUT INCIDENT. THERAPY WAS DELAYED BY 4 MINUTES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599063 ↗
• MalfunctionOct 29, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "SHEATH FOLDED IN ON ITSELF. IAB DIDNT UNFURL". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY, ANOTHER IAB CATHETER WAS INSERTED. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 20557945 ↗
• MalfunctionOct 18, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED VIA MEDWATCH "PER THE REPORT THIS WAS A FAULTY BALLOON PUMP, BALLOON UNDER EXPANDED DURING INFLATION. CATH LAB STAFF WERE AWARE OF THE POTENTIAL DUE TO PREVIOUSLY REPORTED FDA AND DEVICE ALERTS. SO, THEY CHANGED TO A NEW BALLOON PUMP". ADDITIONAL INFORMATION STATES THAT THE PATIENT WAS "DISCHARGED FROM THE HOSPITAL ALIVE, EXEPECTED TO FULLY RECOVER". 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 20481131 ↗
• MalfunctionOct 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED VIA MEDWATCH "HE IABP WAS TURNED OFF AND REMOVED ON [DATE REDACTED]. UPON REMOVAL IT WAS QUICKLY NOTICED THAT THE BALLOON HAD MULTIPLE CLOTS SURROUNDING IT AND WAS COILED SUGGESTING THE BALLOON WAS NEVER FULLY INFLATED". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "UNKNOWN".

  Patient problems: Insufficient Information

  MAUDE report 20461594 ↗
• MalfunctionOct 9, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "IAB FAILED TO UNWRAP". ADDITIONAL INFORMATION STATES "THEY WERE RECEIVING HIGH PRESSURE ALARMS ON THEIR IABP DESPITE EXCHANGING THE IAB". THE SECOND IAB WAS INSERTED INTO THE SAME INSERTION SITE. 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 20411110 ↗
• MalfunctionOct 7, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED "SHEATH FOLDED IN ON ITSELF. ACCORDION STYLE". ADDITIONAL INFORMATION STATES THAT TO CONTINUE THERAPY, ANOTHER IAB C ATHETER WAS INSERTED. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 20383294 ↗
• MalfunctionSep 25, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED "PLACED 50CC ULTRAFLEX IN CCL, HIGH PRESSURE ALARM CONTINUOUSLY, DID NOT PERFORM A MANUAL INFLATION. REMOVEDAND PLACED A 40CC WITH SAME HIGH PRESSURE ALARM". ADDITIONAL INFORMATION STATES "REMOVAL OF 50CC, PLACED A 40CC WITH SAME HIGH PRESSURE ALARM,THE USER RESTARTED THE PUMP ONCE, WITH ANOTHER HIGH PRESSURE ALARM THEN THE USER RESTARTED IT AGAIN AND IABC THEN FULLY INFLATATED TO THE TIP UNDER FLUORO PER INTERVENTIONALIST". THE SECOND IAB WAS INSERTED INTO THE SAME INSERTION SITE. 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 20302633 ↗
• MalfunctionSep 13, 2024Increase in Pressure; Increase in Pressure

  IT WAS REPORTED "EXPERIENCED NUMEROUS HIGH PRESSURE ALARMS, AND EXCHANGED FOR ANOTHER CATHETER". ADDITIONAL INFORMATION STATES THAT THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. 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 20215969 ↗
• MalfunctionSep 6, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED "IAB DID NOT UNWRAP AT DISTAL TIP". TO CONTINUE THERAPY, THE IAB CATHETER WAS REMOVED AND REPLACED. THE SECOND CATHETER WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160051 ↗
• MalfunctionAug 30, 2024Defective Device; Defective Device

  IT WAS REPORTED "DISTAL TIP OF IAB FAILED TO UNWRAP". TO CONTINUE THERAPY ANOTHER IAB WAS INSERTED OF A DIFFERENT MANUFACTURER. THE SECOND IAB WAS INSERTED INTO THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "CRITICAL".

  Patient problems: Insufficient Information

  MAUDE report 20111154 ↗
• MalfunctionJul 24, 2024

  A 50 ML IAB (INTRA-AORTIC BALLOON) CATHETER WAS PLACED UNDER FLUORO GUIDANCE. THE IABP CONSOLE CONTINUED TO GIVE "HELIUM LOSS" ALARM DUE TO THE TOP PORTION OF THE BALLOON NOT INFLATING ADEQUATELY. THERE WAS NO BLOOD IN THE HELIUM LINE. IT WAS EXCHANGED FOR A SECOND 40 ML IAB CATHETER. THE BALLOON TIP AGAIN DID NOT INFLATE ADEQUATELY. CASE WAS DISCUSSED WITH THE ARROW CLINICAL REP VIA PHONE. SEVERAL MANEUVERS EMPLOYED AND THE HELIUM ALARM CONTINUED. A THIRD 40 ML IAB CATHETER WAS PLACED, AND IT FUNCTIONED PROPERLY WITH ADEQUATE INFLATION/DEFLATION AND AUGMENTATION.

  Patient problems: Insufficient Information

  MAUDE report 19816441 ↗