SYNERGY MEGATRON™ H7493942812500Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729985600), received between Jul 19, 2021 and Aug 22, 2025 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 5.00 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SUCCESSFULLY IMPLANTED. DURING WITHDRAWAL, THE BALLOON COULD NOT BE REMOVED THROUGH THE CATHETER. THE PHYSICIAN REMOVED THE CATHETER WITH THE BALLOON STILL ATTACHED. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877333 ↗
• MalfunctionJul 10, 2025Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Difficult to Remove; Material Deformation; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTY OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED CORONARY ARTERY. A 5.00 MM X 12 MM SYNERGY MEGATRON CORONARY DRUG-ELUTING STENT MONORAIL WAS SELECTED FOR USE. DURING WITHDRAWAL, IT WAS NOTED THAT THE BALLOON WOULD NOT PULL BACK ALL THE WAY INTO THE GUIDE CATHETER. THE PHYSICIAN TRIED TO INFLATE/DEFLATE BALLOON MULTIPLE TIMES OF 3-4 ATM TO TRY TO GET THE BALLOON TO REWRAP, BUT STILL UNABLE TO WITHDRAW. THERE WAS A VISIBLE DAMAGE ON THE BALLOON SHOULDER, IT WILL NOT FULLY DEFLATE. PHYSICIAN DECIDED TO REMOVE THE WHOLE SYSTEM INCLUDING THE SDS, GUIDEWIRE, GUIDE CATHETER AND HAD TO REMOVE THE FEMORAL SHEATH AS THE BALLOON WOULD NOT COME OUT FROM THE GUIDE CATHETER. FURTHERMORE, THE TIP OF THE GUIDE CATHETER WAS FLARED AS A RESULT OF TRYING TO REMOVE THE SDS. THE ROTA DRIVE FLOPPY GUIDEWIRE WAS ABLE TO BE REMOVED FROM THE DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472590 ↗
• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.00 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE BROKE IN TWO PIECES. THE DEVICE WAS REMOVED TOGETHER WITH THE GUIDE CATHETER WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657324 ↗
• InjuryMar 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED WHICH REQUIRED ADDITIONAL INTERVENTION. A 5.00 X 12MM SYNERGY MEGATRON DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. IT WAS NOTED THAT DURING LEFT HEART CATHETERIZATION, A STENT FRACTURE OCCURRED. A SECOND STENT WAS DEPLOYED INSIDE THE FRACTURED STENT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18908700 ↗
• InjuryFeb 9, 2024

  DURING LEFT HEART CATHETERIZATION, A STENT FRACTURE OCCURRED. SECOND STENT WAS DEPLOYED INSIDE FRACTURED STENT. NO HARM TO PATIENT.

  Patient problems: Failure of Implant

  MAUDE report 18686147 ↗
• MalfunctionNov 3, 2023Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE OSTIUM OF THE SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 5.00 X 12 MM SYNERGY MEGATRON STENT WAS IMPLANTED SUCCESSFULLY. POST DILATATION WITH THE MEGATRON BALLOON WAS PERFORMED THREE TIMES FOR THE OSTIAL AREA OF THE LESION. UPON REMOVAL FROM THE BODY, THE GUIDEWIRE STARTED COMING BACK. AFTER MULTIPLE ATTEMPTS TO PULL NEGATIVE ON THE BALLOON AND REMOVE, GUIDEWIRE POSITION AND GUIDE CATHETER ENGAGEMENT WERE COMPLETELY LOST. THE DEVICE WAS REMOVED WITH THE GUIDE CATHETER AND GUIDEWIRE THROUGH THE SHEATH. ONCE OUTSIDE OF THE BODY IT WAS NOTED THAT THE MEGATRON BALLOON WAS SEVERELY DEFORMED. ENTIRE INTERVENTIONAL SYSTEM HAD TO BE REPLACED TO FINISH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18069680 ↗
• MalfunctionOct 27, 2023

  AFTER DEPLOYING THE STENT AND POST DEPLOYMENT INFLATION, THE BALLOON WOULD NOT WRAP BACK DOWN TO FIT THROUGH THE GUIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18031683 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IT WAS NOTICED THAT BALLOON WAS FRACTURED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETE WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877940 ↗
• MalfunctionMar 16, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND CALCIFIED VESSEL. A 5.00 X 12MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. WHEN STARTING TO PULL BACK THE DEVICE, THE STENT STARTED TO MOVE ON THE BALLOON BUT NOT DETACHED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 3.50 X 12MM MEGATRON STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16554397 ↗
• MalfunctionOct 5, 2022Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION AND REMOVAL DIFFICULTIES OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED NON TORTUOUS PROXIMAL CIRCUMFLEX ARTERY. A SYNERGY MEGATRON 5.00 X 12MM BALLOON EXPANDABLE STENT WAS SUCCESSFULLY DEPLOYED INTO THE LESION. THE STENT DELIVERY BALLOON WAS DEFLATED TO ZERO FOR 20-30 SECONDS THEN PULLED NEGATIVE ON THE INFLATION DEVICE. THE STENT DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE GUIDE CATHETER. THE WIRE, STENT DELIVERY SYSTEM AND GUIDE CATHETER WERE REMOVED AS ONE UNIT. THE BALLOON WAS NOT COMPLETELY DEFLATED AND TOO BIG TO REMOVED FROM THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544408 ↗
• MalfunctionJul 19, 2021Deflation Problem; Material Integrity Problem; Deflation Problem; Material Integrity Problem

  IT WAS REPORTED THAT FAILURE TO DEFLATE A BALLOON AND BALLOON DAMAGE OCCURRED. A 5.00 X 12MM SYNERGY MEGATRON WAS USED FOR TREATMENT, BUT THE BALLOON ON THE STENT WOULD NOT DEFLATE. IT WAS NOTED THAT WHEN THE BALLOON WAS INSPECTED, IT APPEARED TO BE MANGLED. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12191342 ↗