Linear 7.5Fr. 40cc IAB with Accessories (APA), US Only 0684-00-0480-02URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607567109534), received between Sep 30, 2026 and Sep 30, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Obstruction of Flow

  During an Emergency Support Program call, a Cardiology staff member reported a damped arterial pressure waveform, which was reported to be more damped than earlier in the shift. The customer reported that an X-ray had just been completed and that the Intra-Aortic Balloon Pump (IABP) displayed pressures of 133/52 mmHg (MAP 100 mmHg) with augmentation of 147 mmHg. The customer attempted to aspirate the Linear 7.5Fr. 40cc Intra-Aortic Ballloon (IAB) inner lumen without success. Based on the inability to aspirate, the inner lumen was considered clotted, and the customer was advised to disconnect and discard the pressure tubing connected to the inner lumen, cap the inner lumen, and label it "Do Not Use Due to Risk for Thrombus." It was explained that an alternate arterial pressure source, such as a radial arterial line, would be required for appropriately time balloon inflation and deflation. The customer was successfully instructed on transducing a radial arterial line to the pump. The possibility of transducing the disconnected pressure tubing to the bedside monitor was discussed, and it was clarified that the tubing should be discarded because it was no longer connected to the inner

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943773 ↗