Linear 7.5Fr. 34cc IAB with Accessories (APA), US Only 0684-00-0479-02URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567109510), received between Oct 21, 2020 and Apr 24, 2023 — classified as 2 malfunctions.

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

• MalfunctionApr 24, 2023Leak/Splash; Leak/Splash

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16797473 ↗
• MalfunctionOct 21, 2020No Display/Image; Inflation Problem; Leak/Splash; Pressure Problem; No Display/Image; Inflation Problem; Leak/Splash; Pressure Problem

  IT WAS REPORTED THAT DURING INTRA-AORTIC BALLOON (IAB) THERAPY ON AN ORTHOTOPIC HEART TRANSPLANT PATIENT, THE WAVEFORM WAS DIFFICULT TO MONITOR, AND THE IAB WAS NOT INFLATING. APPROXIMATELY FIVE MINUTES INTO THERAPY, BLOOD WAS SEEN IN THE GAS LINE. THE CONSOLE WAS PLACED ON STANDBY, AND THE IAB WAS REPLACED. THERE WAS NO PATIENT HARM, OR ADVERSE EVENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10710668 ↗