ARROW IPN916138Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10801902167726), received between Dec 19, 2022 and Mar 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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-1878-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Leak/Splash

  IT WAS REPORTED "IAB POSITIVE FOR LEAK". ADDITIONAL INFORMATION STATES THAT THE IAB WAS PLANNED TO BE REMOVED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605828 ↗
• MalfunctionAug 11, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING INSERTION IN A PATIENT IN THE CCL, "THE ARROW IAB DID NOT FULLY UNWRAP WHEN IT WAS INITIALLY CONNECTED TO A MAQUET CARDIOSAVE PUMP". AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB FROM A DIFFERENT BRAND WAS INSERTED AT THE SAME INSERTION SITE. NO PATIENT HARM OR INJURY. 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 17515286 ↗
• MalfunctionJun 28, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FOS SENSOR TIP WAS RECESSED. AS A RESULT, THE IAB WAS REMOVED AND A 2ND IAB WAS INSERTED. PER THE CUSTOMER IT IS UNKNOWN IF THE SAME OR A DIFFERENT INSERTION SITE WAS USED. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17215896 ↗
• MalfunctionJun 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE INSERTION PROCEDURE ON A PATIENT, IT WAS NOTED THAT THE STERILE IAB COVERING SEPARATED FROM PLASTIC BIFURCATION. AS A RESULT, THE IAB WAS REMOVED AND IABP THERAPY WAS DISCONTINUED AS THE PATIENT WAS STABLE. NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198681 ↗
• MalfunctionJun 8, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN ATTEMPTING TO INITIATE THERAPY AFTER IAB INSERTION, THE IAB WAS FOUND TO BE SEVERELY 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 17085886 ↗
• MalfunctionFeb 7, 2023Gas/Air Leak; Gas/Air Leak

  REPORTED AS "MULTIPLE HELIUM LOSS ALARMS". THE REPORT STATES, "CALL DISPATCHED FROM SPEEDEZ. [CLINICIAN] CALLING ABOUT MULTIPLE HELIUM LOSS 3 ALARMS. PER RN, APPROXIMATELY 5-6 ALARMS EVERY 5-10 MINUTES. STRIP OBTAINED SHOWED SLOWED GAS MOVEMENT IN BPW. PATIENT REPOSITIONED, HIP HYPEREXTENDED WITH NO CHANGE IN ALARM FREQUENCY AND MINIMAL IMPROVEMENT IN BPW. LEAK TEST COMPLETED, CATHETER APPEARED TO FAIL ON FACETIME. RECOMMENDED IAB REMOVAL D/T CATHETER ISSUE. FELLOW REMOVED IAB AND DID NOT INSERT NEW IAB. ON FOLLOW UP, RN ENDORSED PATIENT IS STABLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16312689 ↗
• MalfunctionDec 29, 2022Material Twisted/Bent; Material Twisted/Bent

  REPORTED AS "IAB KINKED NEAR THE TIP AND BALLOON WOULD NOT FULLY INFLATE". THE REPORT STATES THAT A" CALL DIRECTION FROM THE SUPPLY SPECIALIST IN THE CATH LAB, SHE WAS GIVEN THIS IAB THIS MORNING THAT WAS INSERTED YESTERDAY BY THE [PHYSICIAN] IN THE CATH LAB. SHE WAS TOLD BY THE STAFF THAT THE CATHETER APPEARED TO BE KINKED AT THE TIP AND WOULD NOT FULLY INFLATE. THEY OBSERVED THE BALLOON UNDER FLUOROSCOPY, AND THIS IS HOW THEY COULD SEE THAT IT WAS NOT FULLY INFLATING. THE [SUPPLY SPECIALIST] DID NOT KNOW IF THERE WERE ANY ALARMS FROM THE PUMP NOR WHICH PUMP WAS USED. THE [PHYSICIAN] REMOVED THIS IAB AND PLACED A SECOND 5850-LWS WITHOUT DIFFICULTY. THE SECOND IAB FUNCTIONED AS IT SHOULD AND WITHOUT ANY ISSUES". THE SECOND IAB WAS PLACED AT THE SAME INSERTION SITE. NO PATIENT INJURY OR CONSEQUENCE. THE PATIENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16074533 ↗
• MalfunctionDec 19, 2022Gas/Air Leak; Gas/Air Leak

  THE REPORT STATES THAT A "CALL PATCHED IN FROM SPEEDEZ. THE [CLINICIAN] CALLED THE HOTLINE FOR HELP WITH TROUBLESHOOTING MULTIPLE, PERSISTENT HELIUM LOSS 2 ALARMS. SHE SAID THAT THEY HAD JUST PLACED THE IAB IN THE CATH LAB A SHORT TIME AGO. THE PUMP IMMEDIATELY STARTED ALARMING FOR POSSIBLE HELIUM LOSS. THEY INITIALLY REDUCED THE VOLUME IN THE BALLOON FROM 50CC TO 40CC IN THE CATH LAB. THIS DID NOT CHANGE THE FREQUENCY OF THE ALARMS. THEY THEN TRIED SWITCHING TO A DIFFERENT PUMP. THE SECOND PUMP IMMEDIATELY STARTED ALARMING WITH THE SAME MESSAGE AS THE ORIGINAL PUMP. THEY THEN TRANSPORTED THE PATIENT TO THE CARDIAC ICU. THIS IS WHEN THE [CLINICIAN] CALLED THE HOTLINE. WE DISCUSSED THE FREQUENCY OF THE ALARMS. SHE SAID THAT THEY HAVE BEEN EVERY 3-5 MINUTES. THE PUMP WAS ALARMING IN THE BACKGROUND AND THE FREQUENCY, WHILE I WAS ON THE PHONE WITH HER, WAS CLOSER TO EVERY MINUTE. I ASKED IF WE COULD FACETIME, BUT THE PATIENT IS IN ISOLATION RELATED TO COVID. SHE DID SEND ME A PICTURE OF THE BPW WITH THE MOST RECENT ALARM. THE BPW APPEARED GROSSLY NORMAL WITH A VERY SLIGHTLY LOW BASELINE, WHICH APPEARED TO BE RIGHT AT ZERO. I EXPLAINED TO HER THAT MOST LIKELY INDICATES A LEAK SOMEWHERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16008009 ↗