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SYNERGY™ H7493926120220Recalls & reported problems

Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant

All models of SYNERGY (74)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729840626), received between Oct 9, 2018 and Oct 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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

  • Device Damaged Prior to Use1
  • Material Deformation1

Patient problems

  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionOct 9, 2018Device Damaged Prior to Use; Material Deformation; Device Damaged Prior to Use; Material Deformation

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 20 SYNERGY STENT WAS SELECTED FOR USE; HOWEVER, THE STENT STRUT WAS NOTED TO BE BROKEN. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 7947687 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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