SYNERGY MEGATRON™ H7493942828500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729985761), received between Jul 14, 2021 and Mar 24, 2025 — classified as 1 injury, 2 malfunctions.

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.

• MalfunctionMar 24, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 28MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC (BSC) GUIDE EXTENSION WAS USED AND IT WAS FOUND THAT IT DOES NOT HAVE A LARGE INNER LUMEN WHICH LED THE STENT HAD DIFFICULTY TO DELIVERED THROUGH THE LESION. THE SHAFT WAS BROKEN WITHIN THE GUIDE EXTENSION. THE DEVICE WAS SIMPLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21684122 ↗
• MalfunctionJul 13, 2022Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Material Rupture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DIFFICULTIES REMOVING A BALLOON AND BALLOON RUPTURE OCCURRED. A 5.00 X 28MM SYNERGY MEGATRON WAS DEPLOYED AT THE SAPHENOUS VEIN GRAFT (SVG). HOWEVER, WHILE DEFLATING THE BALLOON, ISSUES REMOVING THE BALLOON FROM THE STENT OCCURRED. THE BALLOON WAS INFLATED, DEFLATED, AND PULLED TO NEGATIVE. IT WAS NOTED THAT AT SOME POINT THE BALLOON HAD RUPTURED AS BLOOD WAS NOTICED TO HAVE COME BACK INTO THE INFLATION DEVICE. THE BALLOON WAS UNABLE TO BE WITHDRAWN. THE DEVICE WAS REMOVED TOGETHER ON THE WIRE WITH A SPIDER EMBOLIC DEVICE ATTACHED. THE DEVICE WAS REMOVED INTACT. IT WAS NOTED THAT THE STENT APPEARED TO BE UNAFFECTED BY THIS. POST DILATATION WAS NOT PERFORMED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002974 ↗
• InjuryJul 14, 2021Deflation Problem; Material Separation; Obstruction of Flow; Deflation Problem; Material Separation; Obstruction of Flow

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND THE BALLOON DETACHED AND DISLODGED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A NON-BSC EMBOLIC PROTECTION FILTER WAS ADVANCED TO THE LESION BUT FAILED TO CROSS. THE LESION WAS THEN PRE-DILATED WITH A 2.0MM EMERGE BALLOON CATHETER AND THE NON-BSC EMBOLIC PROTECTION FILTER WAS ABLE TO BE DEPLOYED DISTALLY TO THE LESION. A 5.00 X 32MM SYNERGY MEGATRON WAS SUCCESSFULLY DEPLOYED. THEN A 5.00 X 28MM SYNERGY MEGATRON BALLOON EXPANDABLE STENT WAS SUCCESSFULLY DEPLOYED. THE BALLOON OF THE STENT DELIVERY SYSTEM WAS THEN FULLY DEFLATED AND WAS PULLED PROXIMALLY TO POST-DILATE THE PROXIMAL PORTION OF THE DEPLOYED 5.00 X 28MM SYNERGY MEGATRON. AFTER THE POST DILATION, THE BALLOON WOULD NOT FULLY DEFLATE. AN ENDOFLATOR WAS UTILIZED, THE STOPCOCK WAS CLOSED, AND DOUBLE NEGATIVE PRESSURE WAS APPLIED. THE BALLOON WAS THEN SLIGHTLY INFLATED AND ATTEMPTED TO BE DEFLATED WHILE GENTLY PULLING ON THE STENT DELIVERY SYSTEM. THE BALLOON THEN DETACHED FROM THE DELIVERY SYSTEM. THE SEMI INFLATED BALLOON REMAINED IN THE SAPHENOUS VEIN GRAFT. THE SEVERELY DAMAGED STENT DELIVERY SYSTEM WAS THEN REMOVED WITHOUT THE BALLOON

  Patient problems: Discomfort

  MAUDE report 12165829 ↗