SYNERGY MEGATRON™ H7493942812350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729985570), received between Jun 8, 2022 and Dec 1, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025Break; Deformation Due to Compressive Stress; Break; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED OSTIAL CIRCUMFLEX ARTERY. A 3.50 X 12MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT WAS BENT AND THE INTERNAL LUMEN WAS FRACTURED, RESULTING IN CONTRAST LEAKAGE UPON INFLATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER MEGATRON 3.5 16 MM DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678005 ↗
• InjuryDec 22, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT STENT FORESHORTENING OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT MAIN CORONARY ARTERY. A 3.50 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DILATED TO ITS NOMINAL DIAMETER, AND SUBSEQUENTLY, THE LESION OR STENT WAS IMAGED USING INTRAVASCULAR ULTRASOUND AND FOUND TO HAVE BEEN COMPRESSED INTO AN OVAL SHAPE WITH A SIGNIFICANTLY REDUCED AREA. THE PROCEDURE WAS COMPLETED BY IMPLANTING AN ADDITIONAL SYNERGY MEGATRON OF THE SAME DIAMETER, AND THE TWO STENTS WERE ABLE TO MAINTAIN PATENCY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18385946 ↗
• InjuryJun 8, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A DELAY IN TREATMENT AND AN ADVERSE EVENT OCCURRED. A 3.50 X 12MM SYNERGY MEGATRON STENT WAS SELECTED FOR TREATMENT. THE SYNERGY MEGATRON WAS NOT ABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE INABILITY TO CROSS THE LESION RESULTED IN A SIGNIFICANT DELAY IN THE PROCEDURE, RESULTING IN AN UNKNOWN ADVERSE PATIENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634922 ↗