Emerge™ Push H7493919012150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729805991), received between May 30, 2023 and Nov 25, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 25, 2024Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH SEVERE CORONARY ARTERY DISEASE. A 1.50MM X 12MM EMERGE PUSH BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, THE DEVICE BECAME STUCK WHILE CROSSING THE LESION AND WHEN AN ATTEMPT WAS MADE TO REMOVE THE DEVICE, THE BALLOON TIP BROKE. THE REMAINDER OF THE CATHETER WAS SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUSPENDED, AND THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE AT A LARGER HOSPITAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20775339 ↗
• MalfunctionMay 30, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. AN UNKNOWN BOSTON SCIENTIFIC (BSC) BALLOON CATHETER WAS USED; HOWEVER, THE SHAFT WAS BROKE. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS A 1.50MM X 12MM EMERGE PUSH BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17026026 ↗