SYNERGY MEGATRON™ H7493942816400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729985624), received between May 20, 2021 and Feb 16, 2026 — classified as 1 death, 1 injury, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Material Deformation

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 26 ENCORE INFLATOR DEVICE WAS INSERTED. A 4.00 X 16MM SYNERGY MEGATRON? DRUG-ELUTING STENT WAS ADVANCED AND ATTEMPTED TO INFLATE BUT NO PRESSURE WAS ACHIEVED BY THE INFLATOR DEVICE. THE STENT WAS SUBSEQUENTLY REMOVED. HOWEVER, UPON INFLATION OUTSIDE THE PATIENT, A DISTAL SHAFT HOLE WAS NOTICED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY MEGATRON DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344775 ↗
• MalfunctionJul 17, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DIFFICULTY REMOVAL FROM THE STENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. AFTER THE LESION WAS DILATED WITH EMERGE BALLOON CATHETER AND WOLVERINE CUTTING BALLOON, A 4.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY. HOWEVER, UPON REMOVAL, THE BALLOON WAS STUCK AND WAS DIFFICULT TO REMOVE FROM THE STENT. THE WIRE, BALLOON AND GUIDE WERE REMOVED WITH FORCE AND INTACT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337762 ↗
• MalfunctionJun 1, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 4.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER SUCCESSFULLY DEPLOYING THE STENT, THE PHYSICIAN EXPERIENCED A HARD TIME REMOVING THE BALLOON IN THE GUIDE CATHETER. THE BALLOON WAS REINFLATED AND DEFLATED AGAIN, BUT REWRAP FAILED. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT AS A WHOLE UNIT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043768 ↗
• DeathDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT WAS ENROLLED IN THE MEGATRON COHORT OF THE EVOLVE LV XLV STUDY AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS LOCATED IN PROXIMAL LAD (CASS SITE #12) WITH 90% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.5 MM. THE TARGET LESION WAS TREATED WITH DIRECT PLACEMENT OF A 4.00 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2021, 202 DAYS POST INDEX PROCEDURE, SUBJECT EXPIRED DUE TO UNKNOWN EVENT CIRCUMSTANCE AND IN RESPONSE TO THE EVENT NO ACTION WAS TAKEN OR DIAGNOSTICS WERE PERFORMED. THE SUBJECT PASSED AWAY. IT IS UNKNOWN WHETHER AUTOPSY WAS PERFORMED OR NOT. IT WAS FURTHER REPORTED THAT THE PRIMARY CAUSE WAS DEATH WAS DUE TO MULTIPLE DISEASES OF AGING WHICH WAS A CONSEQUENCE OF CORONARY ARTERY DISEASE AND COPD PER DEATH CERTIFICATE.

  Patient problems: Insufficient Information

  MAUDE report 12964323 ↗
• InjuryMay 20, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DIFFICULT TO POSITION A STENT OCCURRED. A CORONARY INTERVENTION WAS PERFORMED ON A 4.00MM CIRCUMFLEX ARTERY (CX) FOR BLOCKAGE. A 4.00 X 16MM SYNERGY MEGATRON WAS ADVANCED, INFLATED BETWEEN 12 TO 16 ATMOSPHERES, AND DEPLOYED IN THE CX OSTIUM. FOLLOWING DEPLOYMENT, THE LESION WAS POST DILATED AND THE STENT APPEARED TO FULLY APPOSED TO THE VESSEL WALL. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. IT WAS NOTED THAT IT WAS WAITED FOR THE BALLOON TO FULLY DEFLATE BEFORE REMOVING THE STENT DELIVERY SYSTEM, AND THERE WAS NO RESISTANCE WHEN REMOVING THE BALLOON FROM THE STENT. FOLLOWING THE STENT DELIVERY SYSTEM REMOVAL FROM THE PATIENT, THE STENT STRUTS APPEARED IN THE LEFT MAIN ARTERY (LM), COVERING THE LEFT ANTERIOR DESCENDING ARTERY (LAD) OSTIUM, 3-5MM. IT WAS NOTED THAT IT APPEARED THAT THE STENT HAD NOT EXTENDED OR STRETCHED INTO THE LM 3-5MM. IT WAS NOTED THAT THE STENT WAS BELIEVED TO HAVE BEEN PLACED CORRECTLY, THE STENT HAD SEEMED TO MOVE, AND IT WAS NOT UNDERSTOOD WHY THE STRUTS APPEARED IN THE LM. THE STENT WAS DEPLOYED IN A RIGHT ANTERIOR OBLIQUE (RAO) WITH CAUDAL ANGULATION VIEW AND NOT IN AN ORTHOGONAL VIEW, SUCH AS A SPIDER VIEW THAT SHOWS THE OSTIU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11857034 ↗