SYNERGY MEGATRON™ H7493942812450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729985594), received between Dec 14, 2021 and Jun 25, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50 X 12MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT WAS DEPLOYED, THE STENT DELIVERY SYSTEM AND THE WIRE WERE REMOVED. HOWEVER, THE DISTAL SHAFT WAS FOUND TO BE BROKEN WHILE THE WIRE WAS STILL INTACT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22330795 ↗
• MalfunctionFeb 13, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, UPON REMOVAL, THE STENT BALLOON GOT LODGED IN THE GUIDE AND THE SHAFT BROKE AT POLYMER TRANSITION. THE DEVICE AND THE GUIDE CATHETER WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695983 ↗
• MalfunctionApr 25, 2023Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. A 4.50 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED TO TREAT THE LESION. HOWEVER, DURING DEFLATION OF THE BALLOON, IT WAS FAILED TO DEFLATE DESPITE OF MULTIPLE ATTEMPTS. THE BALLOON HAD TO BE PULLED OUT TOGETHER WITH THE WIRE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808937 ↗
• MalfunctionApr 12, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT STENT DELIVERY SYSTEM REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.50 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND SUCCESSFULLY IMPLANTED IN THE LESION. HOWEVER, THE PHYSICIAN STRUGGLED TO REMOVE THE STENT DELIVERY SYSTEM (SDS) FROM THE FRESHLY DEPLOYED STENT. IT WAS NOTICED THAT THE DISTAL PLASTIC OF THE SHAFT WAS STRETCHED AND BECAME ELONGATED DURING THE REMOVAL. THE SDS WAS ABLE TO REMOVE INTACT AFTER EXERTING SIGNIFICANT AND MORE WITHDRAWAL FORCE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724185 ↗
• InjuryJul 26, 2022Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET VESSEL WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS LEFT MAIN ARTERY. A 4.5MM X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SUCCESSFULLY IMPLANTED, HOWEVER, THE STENT DELIVERY SYSTEM WAS DIFFICULT TO REMOVE FROM THE STENT. FORCEFUL REMOVAL WAS REQUIRED AND THE CATHETER FRACTURED. AN ATTEMPT TO REMOVE THE FRACTURED CATHETER VIA SNARE WAS UNSUCCESSFUL AND THE DEVICE HAD TO BE REMOVED BY A VASCULAR SURGEON USING A CUTDOWN OF THE BRACHIAL ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOSPITAL ADMISSION BEYOND STANDARD OF CARE WAS REQUIRED, HOWEVER, THE PATIENT IS FULLY RECOVERED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15106088 ↗
• MalfunctionDec 14, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULT TO REMOVE A BALLOON OCCURRED. A 100% STENOSED TARGET LESION WAS LOCATED IN THE NONE TORTUOUS AND MILDLY CALCIFIED LEFT MAIN ARTERY. A 4.50 X 12MM SYNERGY MEGATRON STENT WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THE DEVICE WAS ADVANCED TO THE TARGET LESION AND DEPLOYED WITHOUT ANY PROBLEMS. THE STENT WAS DEPLOYED AT 11 ATMOSPHERES WITH NO ISSUES ENCOUNTERED. THE STENT WAS POST DILATED AT 16 ATMOSPHERES. WHILE WITHDRAWING BALLOON INTO THE GUIDE CATHETER, RESISTANCE OCCURRED. AFTER SEVERAL ATTEMPTS TO DEFLATE THE MEGATRON STENT BALLOON, THE BALLOON BECAME LODGED IN THE NON-BOSTON SCIENTIFIC GUIDE CATHETER AND IT WOULD NOT COME OUT. THE BALLOON WAS FULLY DEFLATED , THE PHYSICIAN REMOVED THE GUIDE CATHETER AND THE STENT BALLOON AS ONE PIECE BY PULLING THE GUIDE CATHETER WITH IT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER GUIDE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE WITH SUCCESSFUL OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13006773 ↗