SYNERGY MEGATRON™ H7493942828350Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729985730), received between Apr 18, 2023 and Jul 11, 2025 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 50-60% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.50 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, A STENT STRUT BROKE WHEN TRYING TO CROSS THE CALCIFIED LESION. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486844 ↗
• MalfunctionMay 9, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 3.50 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DEFORMED. WHEN THE DEVICE WAS REMOVED, THE MID SHAFT BROKE. EVERYTHING CAME OUT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279333 ↗
• InjuryJul 10, 2023Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST-DEPLOYMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED AORTO-OSTIAL RIGHT CORONARY ARTERY (RCA). A 3.50 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER INITIAL DEPLOYMENT OF THE STENT, INTERACTION WITH THE GUIDE CATHETER CAUSED AXIAL DEFORMATION OF THE STENT. AS A RESULT, SUBSEQUENT POST INFLATION BALLOONING WAS MADE DIFFICULT. A NEW WIRE WAS PLACED OUTSIDE THE FIRST ROW OF MEGATRON STENT STRUTS AND BALLOONS WERE USED IN A "CRUSH" TECHNIQUE TO CREATE AN OPENING. THEN, A NEW STENT WAS DEPLOYED AT THE OSTIUM RCA AND THE PROCEDURE WAS SUCCESSFUL. THE PATIENT THEN UNDERWENT ANGIOGRAM OF THE TARGET LESION LOCATED IN THE NON-TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY. A 2.50MM X 12MM NC EMERGE WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, THE HYPOTUBE BROKE JUST PROXIMAL TO THE BALLOON AND REMAINED INSIDE THE PATIENT. A NEW STENT WAS PLACED TO PIN THE BALLOON FRAGMENT ONTO ANOTHER STENT TO AVOID MIGRATION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290591 ↗
• MalfunctionApr 18, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.50 X 28MM SYNERGY MEGATRON WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN INSERTING THE MEGATRON INTO THE GUIDE, THE SHAFT SNAPPED IN HALF AT THE MIDDLE OF THE DELIVERY SYSTEM. THE PIECES WERE REMOVED WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16765597 ↗