SYNERGY MEGATRON™ H7493942832400Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729985785), received between Jul 8, 2021 and Nov 17, 2025 — classified as 1 death, 6 malfunctions.

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

• MalfunctionNov 17, 2025Material Rupture; Failure to Unfold or Unwrap; Material Rupture; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT BALLOON RUPTURED, PREVENTING SUCCESSFUL DEPLOYMENT OF THE STENT. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568631 ↗
• MalfunctionSep 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION, THE BALLOON GOT DISPLACED WHILE BEING POSITIONED IN THE ARTERY. THE DEVICE WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994734 ↗
• MalfunctionMay 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ATTEMPTING TO DEPLOY THE STENT, THE BALLOON RUPTURE DURING INFLATION. THE BALLOON WOULD NOT INFLATE, AND STENT WAS NOT DEPLOYED. SO, STENT WAS REMOVED INTACT AND NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048651 ↗
• MalfunctionSep 22, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY TO LEFT MAIN CORONARY ARTERY. AFTER A 7F GUIDE CATHETER WAS INTRODUCED, A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED TO TREAT THE LESION. HOWEVER, DURING REMOVAL, DESPITE MULTIPLE DEFLATIONS, THE BALLOON COULD NOT BE REMOVED FROM THE STENT. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDE CATHETER AND GUIDE WIRE AS ONE UNIT. AN ADDITIONAL GUIDE CATHETER AND WIRE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797747 ↗
• MalfunctionJul 14, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND CATHETER ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT MAIN CORONARY ARTERY. A 4.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT BALLOON WAS INFLATED AT 14 ATMOSPHERES FOR ROUGHLY 15 SECONDS AND THE STENT WAS DEPLOYED. AFTER WAITING 20-30 SECONDS FOR THE BALLOON TO FULLY DEFLATE, REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE STENT BALLOON BECAME STUCK IN THE PROXIMAL PORTION OF THE GUIDE CATHETER AND THE GUIDEWIRE APPEARED TO BE STUCK TO THE BALLOON. THE BALLOON WAS STILL STUCK EVEN AFTER PULLING BACK PRESSURE/VACUUM ON THE INDEFLATOR A SECOND TIME. THE STENT BALLOON, WIRE, AND GUIDE CATHETER HAD TO BE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17329879 ↗
• MalfunctionOct 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHAFT SEPARATION OCCURRED. A 4.00 X 32MM SYNERGY MEGATRON MR US STENT WAS SELECTED FOR USE IN A RIGHT CORONARY ARTERY CHRONIC TOTAL OCCLUSION PERCUTANEOUS CORONARY INTERVENTION (RCA CTO PCI). WHILE STENTING THE RCA CTO, THE STENT WAS PLACED AND DEPLOYED SUCCESSFULLY AFTER PRE-DILATION WITH AN NC EMERGE BALLOON. UPON ATTEMPTED REMOVAL OF THE DELIVERY SYSTEM, THE BALLOON SHAFT SEPARATED FROM THE HYPOTUBE. REMOVAL WAS SUCCESSFUL WITH A GUIDE TRAPPING TECHNIQUE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539687 ↗
• DeathJul 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) STUDY. IT WAS REPORTED THAT DEATH OCCURRED. IN (B)(6) 2021, THE SUBJECT PRESENTED WITH MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 80% STENOSIS AND WAS 20 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF 4.0 MM X 32 MM STUDY STENT AND A 3.5 X 48 MM SYNERGY STENT IN AN OVERLAPPING FASHION. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0%. THE NEXT DAY, THE SUBJECT WAS DISCHARGED ON CLOPIDOGREL. IN (B)(6) 2021, A STAGED PROCEDURE WAS PERFORMED. NON-TARGET LESIONS FROM THE LEFT MAIN CORONARY ARTERY INTO THE LEFT CIRCUMFLEX ARTERY (LCX) WERE TREATED USING A 3.5 MM X 16 MM SYNERGY MEGATRON STENT AND A NON-TARGET LESION OF THE PROXIMAL LCX WAS TREATED USING A 3.00 MM X 38 MM SYNERGY STENT IN AN OVERLAPPING FASHION. DURING THE STAGED PROCEDURE, THE LEFT ANTERIOR DESCENDING ARTERY WAS SUCCESSFULLY CROSSED INTO THE DIAGONAL BRANCH AND DILATED WITH BALLOON ANGIOPLASTY. THE SUBJECT WAS NOTED TO HAVE A PERFORATION IN THE DIAGONAL BRANCH WHICH WAS INITIALLY MANAGED WITH PROLONGED BALLOON INFLATION AND SUBSEQUENTLY PERICARDIOCEN

  Patient problems: Cardiac Enzyme Elevation; Heart Failure/Congestive Heart Failure; Hypoxia

  MAUDE report 12139984 ↗