MEGA 7.5Fr. 30cc IAB with Accessories, US Only 0684-00-0294-01URecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10607567109572), received between Sep 24, 2026 and Sep 24, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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-2219-2023 · 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 24, 2026Fluid/Blood Leak; Material Twisted/Bent

  It was reported by a direct call from the customer to the Emergency Support Program, that during use of MEGA 30cc balloon catheter a Restriction alarm was displayed on Cardiosave pump and blood was observed in the helium tubing. The reporting ICU nurse stated he had attempted to troubleshoot the alarm by pressing the Start key. He was instructed to discontinue IAB therapy immediately, disconnect the helium tubing from the pump, clamp the extracorporeal tubing, and notify the provider for immediate catheter removal. During follow-up approximately one hour later, the reporter confirmed that the IAB catheter had been removed without complication and that no blood had reached the pump. No harm to the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881759 ↗