Linear 7.5Fr. 34cc IAB (with APA) 0684-00-0479-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10607567106540), received between Nov 9, 2021 and Jul 3, 2025 — classified as 1 death, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• DeathJul 3, 2025Burst Container or Vessel; Leak/Splash; Optical Problem; Burst Container or Vessel; Leak/Splash; Optical Problem

  IT WAS REPORTED FIRST THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, A FAILURE OCCURRED IN THE FIBER OPTIC SENSOR MODULE, RESULTING IN THE BALLOON RUPTURING INSIDE THE PATIENT. ALTHOUGH NO COMPLICATIONS DIRECTLY RELATED TO THE BALLOON RUPTURE WERE REPORTED, THE PATIENT SUBSEQUENTLY DIED.

  Patient problems: Insufficient Information

  MAUDE report 22396736 ↗
• MalfunctionDec 27, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING IAB THERAPY, THERE WAS A RESTRICTION IN THE CATHETER. THERE WAS NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21025314 ↗
• MalfunctionNov 21, 2024Restricted Flow rate; Restricted Flow rate

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY, WHEN PERFORMING THE TEST TO START THE PASSAGE OF THE IAB, OCCLUSION OF THE SAME WAS IDENTIFIED. IT WAS NECESSARY TO OPEN A NEW KIT. THERE WAS NO REPORTED INJURY OR ADVERSE EVENT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20753982 ↗
• MalfunctionMar 14, 2023Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16537772 ↗
• MalfunctionFeb 14, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT WITH DECOMPENSATED HEART FAILURE AND A HISTORY OF HEART TRANSPLANTATION IN 2019 WAS IN NEED OF URGENT INTRA-AORTIC BALLOON (IAB) THERAPY. THE IAB WAS INSERTED WITHOUT IMPROVEMENT IN BLOOD PRESSURE. THE CONSOLE GENERATED A GAS LOSS IN IAB CIRCUIT ALARM AND BLOOD WAS SEEN ENTERING THE IAB CATHETER. THE IAB WAS REMOVED AND REPLACED WITH A NEW ONE TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371284 ↗
• MalfunctionOct 4, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING INSERTION OF THE INTRA-AORTIC BALLOON (IAB) THE SHEATH COULD NOT BE INSERTED THROUGH THE GUIDEWIRE BECAUSE THE DILATOR IN THE SHEATH WAS BLOCKED. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538089 ↗
• MalfunctionSep 16, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) COULD NOT BE INSERTED THROUGH THE SHEATH. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15440892 ↗
• MalfunctionDec 16, 2021Difficult to Insert; Unraveled Material; Difficult to Insert; Unraveled Material

  IT WAS REPORTED THAT THE CUSTOMER COULD NOT INSERT THE INTRA-AORTIC BALLOON (IAB) DUE TO THE BALLOON MEMBRANE BEING UNFURLED. A NEW IAB WAS INSERTED TO CONTINUE THERAPY. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019879 ↗
• MalfunctionNov 9, 2021No Apparent Adverse Event; No Apparent Adverse Event

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781665 ↗