SYNERGY MEGATRON™ H7493942832500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729985808), received between Mar 23, 2023 and Apr 12, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2024Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem; Difficult to Remove; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND BALLOON DETACHMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 5.00 X 32MM SYNERGY MEGATRON WAS ADVANCED FOR TREATMENT AND DEPLOYED. THE BALLOON WAS FULLY DEFLATED. HOWEVER, DURING THE PROCEDURE, EVEN THOUGH THE BALLOON WAS FULLY DEFLATED, THE PHYSICIAN HAD DIFFICULTY REMOVING THE BALLOON. WHEN THE BALLOON WAS PULLED BACK, THE BALLOON WAS PARTIALLY DETACHED FROM THE SHAFT. 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 19102407 ↗
• InjuryNov 17, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY REMOVAL AND SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 5.00 X 32MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS IMPLANTED SUCCESSFULLY. DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE BALLOON BECAME STUCK. DUE TO THE CATHETER SHAFT STRETCHING FROM PULLING, THE SHAFT BROKE PROXIMAL TO THE STENT BALLOON BUT DISTAL TO THE PROXIMAL SHAFT INSIDE THE PATIENT. PART OF THE SHAFT WAS REMOVED, BUT THE BALLOON WAS STILL IN THE BODY. THE DETACHED PORTION WAS TRAPPED IN THE GUIDE WITH A TRAPPER DEVICE AND PULLED OUT AS A SINGLE SYSTEM IN A PARTIALLY INFLATED STATE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18164914 ↗
• InjuryNov 15, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREPARED USING A 1.75 MM ROTAPRO BURR FOLLOWED BY A 6.00 MM NON-COMPLIANT BALLOON. A 5.00 X 32 MM SYNERGY MEGATRON WAS DEPLOYED AND UPON REMOVAL THE SHAFT BROKE 11 CM FROM THE DISTAL TIP. THE BALLOON WITH A PORTION OF THE SHAFT WAS LEFT IN THE BODY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE FRAGMENT WITH A GUIDEZILLA UNSUCCESSFULLY. A SNARE WAS USED TO RETRIEVE THE REMAINING PIECE OF THE DEVICE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145656 ↗
• InjuryJul 10, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT ANGIOGRAM OF THE TARGET LESION LOCATED IN THE NON-TORTUOUS MID TO DISTAL RIGHT CORONARY ARTERY. A 5.00 X 32MM SYNERGY MEGATRON WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, THE HYPOTUBE BROKE JUST PROXIMAL TO THE BALLOON AND REMAINED INSIDE THE PATIENT. A NEW STENT WAS PLACED TO PIN THE BALLOON FRAGMENT ONTO ANOTHER STENT TO AVOID MIGRATION. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE DEFLATION PERIOD BEFORE REMOVAL WAS UNDERDETERMINED BUT IT WAS FULLY DEFLATED WITH NO VISIBLE CONTRAST ON FLUORO.

  Patient problems: Foreign Body In Patient

  MAUDE report 17290020 ↗
• MalfunctionMay 16, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 5.00 X 32MM SYNERGY MEGATRON DRUG ELUTING STENT WAS ADVANCED AND IMPLANTED FOR TREATMENT. HOWEVER, THE STENT DELIVERY SYSTEM WAS STUCK ON THE NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE FOLLOWING DEPLOYMENT OF STENT. THE ENTIRE SYSTEM WAS PULLED OUT TOGETHER AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942669 ↗
• 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 16600272 ↗