SYNERGY MEGATRON™ H7493942808400Recalls & reported problems
Boston Scientific Corporation · Everolimus-Eluting Platinum Chromium Coronary Stent System · Class 3 · Implant
All models of SYNERGY MEGATRON (28)
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 08714729985549), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 65% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT MAIN/CIRCUMFLEX ARTERY. AFTER A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE CROSSED THE LESION AND A 7F NON-BSC GUIDE CATHETER WAS ENGAGED, PRE-DILATATION WAS PERFORMED USING A 2.5MM NON-BSC BALLOON CATHETER FOLLOWED BY A 3.5MM WOLVERINE CUTTING BALLOON. A 3.50 X 28MM SYNERGY MEGATRON WAS ADVANCED FOR TREATMENT. THE STENT WAS PLACED AT 18 ATMOSPHERES AND WELL POSITIONED; HOWEVER, STENT SHORTENING WAS OBSERVED UNDER ANGIOGRAPHY. A 4.00 X 8MM SYNERGY MEGATRON WAS THEN ADVANCED AND PLACED PROXIMAL TO THE FIRST STENT. AFTER DEFLATING THE STENT BALLOON FOR A DELIBERATELY LONG TIME, THE BALLOON STILL HUNG UP AND WAS DIFFICULT TO REMOVE FROM THE STENT. THE BALLOON HAD DIFFICULTY COMING BACK IN THE GUIDE CATHETER AND THE GUIDE CATHETER TIP BECAME DAMAGED. ATTEMPTS WERE MADE TO DEFLATE THE BALLOON FURTHER AND EVENTUALLY THE PARTIALLY INFLATED BALLOON WAS PULLED OUT INTACT. POST-DILATATION WAS PERFORMED WITH A 4.00 X 8MM NC EMERGE BALLOON AND THE PROCEDURE COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642217 ↗
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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