Linear 7.5Fr 40cc IAB with Accessories (APA) (Turkey) 0684-00-0480-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567113159), received between Jun 19, 2023 and Sep 16, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 23, 2023Class IIOpen, Classified

   During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage to the femoral artery, descending aorta, or embolization; surgical intervention and delay of IAB therapy may also result. Firm has received 10 complaints, including 3 serious adverse events and 1 patient death.

   Z-2223-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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.

• MalfunctionSep 16, 2026Difficult to Insert

  It was reported that during the procedure, the Linear 40cc balloon catheter did not pass through the sheath from the initially opened package. Subsequently, a new package was opened, the other balloon was used, and it successfully passed through the sheath. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50784205 ↗
• MalfunctionJun 19, 2023Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash

  IT WAS REPORTED THAT WHEN INTRA-AORTIC BALLOON (IAB) THERAPY WAS ABOUT TO BE INITIATED, THE CONSOLE GENERATED AN ALARM AND BLOOD WAS SEEN IN THE IAB. WHEN THE IAB WAS CHECKED, A SMALL HOLE WAS NOTICED AT THE TIP. 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 17152216 ↗