MEGA 7.5Fr. 40cc IAB with Accessories, US Only 0684-00-0295-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567109596), received between Jul 29, 2026 and Aug 11, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (1 report).

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.

• MalfunctionAug 11, 2026Obstruction of Flow

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208066 ↗
• InjuryJul 29, 2026Fluid/Blood Leak; Difficult to Remove; Material Rupture

  On (B)(6) at 08:05, while assisting the patient to the toilet, the bedside Registered Nurse (RN) observed blood in the intra-aortic balloon pump (IABP) helium line, indicating a suspected MEGA 40cc Intra-Aortic Balloon (IAB) rupture. The Respiratory Therapist (RT) responded promptly to assess the situation. In accordance with standard practice, the IABP was immediately turned off, and the helium line was clamped to prevent further blood entry into the balloon. A critical care physician attempted to remove the IAB catheter; however, significant resistance was encountered during extraction. During the removal attempt, the patient developed stroke-like symptoms, including weakness and headache. Cardiothoracic Surgery was consulted and successfully removed the catheter without further complication.Following catheter removal, the patient's neurological symptoms resolved completely. Computed tomography (CT) scans of the head and chest were performed to evaluate for potential complications. Both studies were unremarkable, with no evidence of acute intracranial pathology, vascular injury, or other procedure-related complications. The patient remained hemodynamically stable, and a replaceme

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50065656 ↗