SYNERGY MEGATRON™ H7493942824350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729985693), received between Jan 23, 2023 and Mar 25, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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.

• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS IMAGING CATHETER WAS USED BUT BECAME KINKED INSIDE THE PATIENT DURING DELIVERY POST-STENT PLACEMENT, RESULTING IN A LOSS OF IMAGING. THE DEVICE WAS REMOVED, AND A 2.25 X 38 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT BROKE AT THE PROXIMAL STAINLESS-STEEL SHAFT AND SNAPPED INSIDE THE PATIENT. THE DEVICE WAS REMOVED, AND ANOTHER 3.50 X 24 MM SYNERGY XD DES WAS THEN SELECTED, BUT IT ALSO BROKE AT THE PROXIMAL STAINLESS-STEEL SHAFT AND SNAPPED INSIDE THE PATIENT. THE DEVICE WAS ALSO REMOVED BY JUST PULLING THEM BACK OUT OVER THE WIRE. THE HUB OF BOTH STENTS WAS DETACHED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21689224 ↗
• InjuryJan 2, 2025Activation Failure; Activation Failure

  VITALYST EARLY FEASIBILITY STUDY. IT WAS REPORTED THAT STENT WAS NOT WELL APPOSED. DURING THE INDEX PROCEDURE, THE 80% STENOSIS IN THE LEFT OSTIAL TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND IN THE LCX WAS TREATED BY ANGIOPLASTY USING 2.50 MM NON-COMPLIANT BALLOONS FOLLOWED BY INTRAVASCULAR ULTRASOUND IMAGING (IVUS) OF EACH VESSEL. SUBSEQUENTLY, SEVERE CALCIFICATION IN THE PROXIMAL LAD AND PROXIMAL LCX WAS TREATED WITH ANGIOPLASTY USING A 3.00 MM NON-COMPLIANT BALLOON AND A NON-BOSTON SCIENTIFIC LITHOTRIPSY BALLOON FOLLOWED BY ANGIOPLASTY USING A 3.50 MM WOLVERINE CUTTING BALLOON. TWO 3.50 MM X 24.00 MM SYNERGY MEGATRON DES WERE IMPLANTED FOLLOWED BY PROXIMAL OPTIMIZATION TECHNIQUE USING A 4.00 MM BALLOON. A PROXIMAL MAL APPOSITION NOTED IN THE LMCA SEGMENT OF THE STENT WAS POST-DILATED USING A 5.00 MM BALLOON. IN ADDITION, A CONTAINED PERFORATION WAS NOTED IN THE LMCA WHICH WAS TREATED BY BALLOON ANGIOPLASTY WITH SERIAL INFLATIONS USING A 4.00 MM PTCA BALLOON WHICH STOPPED ALL EXTRAVASATIONS. ECHOCARDIOGRAM REVEALED GOOD RESULT WITH NO PERICARDIAL EFFUSION. POST INTERVENTION LESION ASSESSMENT REVEALED, TIMI 3 FLOW AND 0% RESIDUAL STENOSIS. ESTIMATED BLOOD LOSS WAS NOTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21060440 ↗
• MalfunctionJan 23, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH ANGINA AND WAS BEING TREATED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI). THE TARGET LESION WAS MODERATELY CALCIFIED VESSEL. A 3.00 X 28MM SYNERGY XD AND A 3.50 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF BOTH STENTS THROUGH GUIDELINER, THE MID SHAFT OF BOTH SYNERGY MEGATRON STENT BROKE. THE WHOLE DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. A NON-BSC DEVICES WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT A 6 FRENCH GUIDE CATHETER WITH A 6 FRENCH GUIDELINER WERE USED DURING INSERTION OF THE STENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229833 ↗