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Emerge™ H7493918920350Recalls & reported problems

Boston Scientific Corporation · PTCA Dilatation Catheter · Class 2

All models of Emerge (54)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729806363), received between May 3, 2017 and May 3, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Rupture” (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

Device problems

  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 3, 2017Material Rupture

    CCL BOSTON SCIENTIFIC PTCA RUPTURED DURING INFLATION IN CORONARY ARTERY, REMOVED, NEW ITEM OBTAINED TO COMPLETE CATH.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6547658 ↗

Other Catheters, transluminal coronary angioplasty, percutaneous devices

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Sources and updates

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