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Promus PREMIER™ H7493925216350Recalls & reported problems

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

All models of Promus PREMIER (56)

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 08714729828891), received between Mar 15, 2017 and Mar 15, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 Markings/Labelling Problem1

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.

  • MalfunctionMar 15, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT THE PRODUCT WAS MISLABELED. A 16 X 3.50 PROMUS PREMIER¿ DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS LONGER THAN THE STATED SIZE. THE DEVICE WAS REMOVED AND EXCHANGED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6407572 ↗

Other Coronary drug-eluting stent devices

All Coronary drug-eluting stent devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page