SYNERGY MEGATRON™ H7493942820500Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729985686), received between Mar 15, 2021 and Jun 16, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 16, 2026Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS CORONARY ARTERY. AFTER PRE DILATION OF THE LESION, A 5.00 X 20MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS DEPLOYED. DURING WITHDRAWAL OF THE BALLOON CATHETER, IT WAS OBSERVED THAT THE BALLOON WOULD NOT EXIT THE STENT. INFLATION OF THE BALLOON TO 8 ATM WAS PERFORMED, AFTER WHICH DEFLATION AND ANOTHER ATTEMPT TO WITHDRAW WERE MADE. THE BALLOON STILL COULD NOT BE REMOVED FROM THE STENT INTO A NON-BOSTON SCIENTIFIC GUIDE CATHETER. ADDITIONAL INFLATIONS WERE PERFORMED TWO OR THREE MORE TIMES TO REMOVE ALL CONTRAST FROM THE BALLOON. PARTIAL WITHDRAWAL WAS THEN ACHIEVED, AND THE BALLOON WAS ADVANCED APPROXIMATELY HALFWAY INTO THE GUIDE CATHETER, HOWEVER; THE STENT SHAFT FRACTURED WITHIN THE GUIDE CATHETER. SNARING WAS USED TO REMOVE ALL THE FRAGMENTS AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25520936 ↗
• InjurySep 15, 2025Break; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Break; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 20MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, UPON REMOVAL OF THE CATHETER, IT WAS NOTICED THAT THE SHAFT OF THE BALLOON WAS BROKEN. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23052883 ↗
• MalfunctionNov 8, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 5.00 X 20 MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, USING A 6F NON-BOSTON SCIENTIFIC GUIDE CATHETER AND A 6F GUIDEZILLA GUIDEWIRE. HOWEVER, ONCE DEFLATED, THE MEGATRON BALLOON WOULD NOT PASS THROUGH THE GUIDEZILLA AND BECAME DETACHED FROM THE SHAFT. ALL COMPONENTS WERE REMOVED AS ONE SYSTEM, LEAVING NOTHING IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20637164 ↗
• MalfunctionOct 2, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA), AND A 5.00 X 20 MM SYNERGY MEGATRON STENT WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE STENT WAS PLACED INTO THE GUIDE LINER AND DETACHED FROM THE BALLOON WHILE STILL WITHIN THE GUIDE LINER, RESULTING IN THE STENT APPEARING SLIGHTLY CRUSHED BACKWARD. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20355373 ↗
• MalfunctionJul 8, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.00 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS IMPLANTED FOR TREATMENT. HOWEVER, UPON DEFLATION, THE BALLOON EXPERIENCED GREAT DIFFICULTY COMING OUT OF THE DEPLOYED STENT. THE BALLOON WAS UNABLE TO BE PULLED BACK INTO THE GUIDE CATHETER. THE ENTIRE GUIDE AND THE BALLOON WAS REMOVED TOGETHER FROM THE BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690408 ↗
• MalfunctionMar 23, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY. A BOSTON SCIENTIFIC INFLATION DEVICE WAS USED DURING THE PROCEDURE WITH THE SALINE CONTRAST RATIO OF 50/50. A 5.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS ADVANCED AND IMPLANTED. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE WELL, AND WAS DIFFICULT TO TRACK BACK THROUGH THE GUIDE. ANOTHER 5.00 X 20MM SYNERGY MEGATRON DES WAS IMPLANTED; BUT SAME ISSUE WAS ENCOUNTERED. THE FIRST BALLOON WAS ABLE TO BE REMOVED AND THE SECOND BALLOON HAD TO BE REMOVED WITH THE GUIDE AND THE WIRE. THE VESSEL WAS RESELECTED AND RE-WIRED TO POST DILATE THE LESION WITH A 5.5X15 NC EMERGE BALLOON CATHETER WHICH HAD NO ISSUES IN DEFLATING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16600273 ↗
• InjuryAug 9, 2021Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT A BALLOON DETACHED. AN INTERVENTION TO THE SAPHENOUS VEIN GRAFT (SVG) TO THE CIRCUMFLEX (CX) WAS PERFORMED. IT WAS NOTED THAT THE TARGET LESION WAS PRESUMED TO BE A 7MM SAPHENOUS VEIN GRAFT DIAMETER, THE LESION WAS NOTED TO BE TIGHT, WITH A TIGHT ANGLE. A NON BOSTON SCIENTIFIC (NON BSC) BALLOON WAS ADVANCED TO PREDILATE THE VESSEL. A NON BSC STENT WAS SELECTED FOR TREATMENT, BUT COULD NOT TRACK OVER A NON BSC WIRE, BACKED OUT OF THE GUIDE CATHETER, AND PULLED THE NON BSC FILTERWIRE OUT OF THE VEIN GRAFT. THE VESSEL WAS REWIRED WITH A TRAVERSE AND A NON BSC FILTERWIRE WAS INSERTED. A 5.00 X 20MM SYNERGY MEGATRON WAS ADVANCED TO THE TARGET LESION AND DEPLOYED, BUT WHEN ATTEMPTING TO REMOVE THE DELIVERY SYSTEM, THE BALLOON WAS STUCK. THE INDEFLATOR WAS SET TO NEGATIVE PRESSURE, BUT THE BALLOON WOULD NOT ADVANCE OR PULL BACK INTO THE GUIDE CATHETER. IT WAS NOTED THAT THE BALLOON WAS STUCK IN THE STENT RIGHT AFTER DEPLOYMENT AND NEVER MADE IT INTO THE GUIDE CATHETER. ANOTHER WIRE WAS INSERTED INTO THE VEIN GRAFT, A 3.00 X 20 APEX BALLOON WAS PLACED NEXT TO THE STENT BALLOON, THE BALLOON WAS INFLATED, AND THERE WAS AN ATTEMPT TO DRAG THE STENT BALLOON BACK INTO THE G

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297454 ↗
• InjuryJul 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) POST MARKET STUDY: IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND STENT THROMBOSIS OCCURRED. ON (B)(6) 2021 AND PRIOR TO PROCEDURE, THE SUBJECT WAS FOUND TO HAVE INDICATION FOR MYOCARDIAL INFARCTION (MI) AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 5.00 X 20MM STUDY STENT. ONE DAY POST PROCEDURE, CARDIAC ENZYMES WERE NOTED TO BE ELEVATED. LEFT HEART CATHETERIZATION WAS PERFORMED AND THE SUBJECT WAS DIAGNOSED WITH STENT THROMBOSIS. MYOCARDIAL INFARCTION (MI) WAS DIAGNOSED BASED ON SYMPTOMS SUGGESTIVE OF MI WITH THE LOCATION OF MI TO BE ANTERIOR (SEPTAL). THE MI NOTED WAS NOT A Q WAVE MI. IN RESPONSE TO THE EVENT, LEFT HEART CATHETERIZATION WITH PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AND MEDICATIONS WERE ADMINISTERED. ON (B)(6) 2021, THE EVENT WAS CONSIDERED TO BE RECOVERING AND RESOLVED, AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 12106278 ↗
• MalfunctionMar 15, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT STENT BALLOON REMOVAL DIFFICULTY OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED ON A 90% STENOSED, MILDLY CALCIFIED AND MILDLY TORTUOUS LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED WITH A BALLOON CATHETER. A 5.00 X 20MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DELIVERED USING A 7F GUIDEZILLA II EXTENSION CATHETER. WHILE REMOVING THE STENT BALLOON AND ATTEMPTING TO KEEP THE GUIDE ENGAGED, THE PHYSICIAN SENSED SOME RESISTANCE WITH THE BALLOON AND THE GUIDEZILLA II. THE PHYSICIAN KEPT ATTEMPTING TO REMOVE THE STENT BALLOON WHILE KEEPING THE GUIDE ENGAGED BUT WAS UNABLE TO DO SO. THE BALLOON WOULD NOT PASS THROUGH THE GUIDEZILLA II AFTER DEPLOYING THE STENT. BOTH THE STENT BALLOON AND GUIDEZILLA II HAD TO BE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS ABLE TO BE CONTINUED. THE 0.014 INCH GUIDEWIRE WAS NEVER REMOVED AND THE PHYSICIAN WAS ABLE TO POST DILATE THE STENTS AND COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488259 ↗