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SYNERGY™ H7493926116300Recalls & 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 08714729840596), received between Nov 26, 2019 and Nov 26, 2019 — classified as 1 malfunction.

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

  • MalfunctionNov 26, 2019Material Deformation; Material Deformation

    IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00X16MM SYNERGY DRUG-ELURING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT STRUT WAS BENT DURING PREPARATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.00X16MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 9380363 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

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