MEGA 7.5Fr. 40cc IAB with Accessories (APA), US Only 0684-00-0295-02URecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10607567109602), received between Sep 1, 2026 and Sep 24, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• MalfunctionSep 24, 2026Fluid/Blood Leak

  It was reported by the customer that during use of MEGA 40cc Intra-Aortic Balloon (IAB) catheter blood was observed in the helium line on (b)(6) 2026 at approximately 08:00. The patient was ambulatory on a daily basis during therapy. Approximately 11 days after insertion, a small subcutaneous hematoma near the insertion site was documented. No additional issues were reported prior to the rupture event. Following identification of blood in the helium tubing, the catheter was removed on (b)(6) 2026 at 08:00. Total dwell time was approximately 18 days, 11 hours, and 7 minutes. Catheter removal was completed without complication, and no adverse events associated with the removal procedure were reported. The balloon catheter was inserted via the left axillary artery in the catheterization laboratory.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50880396 ↗
• MalfunctionSep 1, 2026Break; Fluid/Blood Leak; Leak/Splash; Off-Label Use; Obstruction of Flow; Material Deformation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50537072 ↗