SYNERGY™ H7493926112250Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729840510), received between Jan 3, 2019 and Sep 30, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Misassembled During Manufacturing /Shipping” (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 Misassembled During Manufacturing /Shipping1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2021Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
IT WAS REPORTED THAT A MARKERBAND ISSUE WAS ENCOUNTERED. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE MARKERS (90CM AND 100CM) ON THE SHAFT WERE SWITCHED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12554069 ↗MalfunctionJan 3, 2019Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PHYSICIAN NOTICED THAT COATING OR STRUT MATERIAL WAS PEELING OFF, WHILE TRYING TO PASS THROUGH A STENT IN THE RIGHT CORONARY ARTERY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8214363 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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