MEGA 8Fr. 50cc IAB (INDIA) 0684-00-0498-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10607567109756), received between Mar 29, 2023 and Jun 5, 2025 — classified as 3 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-2220-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2025Fluid/Blood Leak; Explosion; Fluid/Blood Leak; Explosion

  WE JUST RECEIVED A CALL FROM (B)(6), A CUSTOMER FROM (B)(6) HOSPITAL (ACCOUNT #(B)(4), REPORTING THAT AN INTRA-AORTIC BALLOON (IAB) CATHETER EXPLODED WHILE BEING USED ON A PATIENT YESTERDAY.

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

  MAUDE report 22147915 ↗
• MalfunctionApr 10, 2023Inflation Problem; Inflation Problem

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16708372 ↗
• MalfunctionMar 29, 2023Device Alarm System; Leak/Splash; Device Alarm System; Leak/Splash

  IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED DURING A HEART TRANSPLANT PROCEDURE. DURING THE PROCEDURE, THE CONSOLE GENERATED AN ALARM AND BLOOD WAS SEEN IN THE TUBING. TWO MINUTES LATER, A NEW IAB WAS INSERTED TO CONTINUE THERAPY WITHOUT FURTHER ISSUE. THE PATIENT WAS SUCCESSFULLY WEANED OFF THERAPY 2 DAYS LATER. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16637743 ↗