SYNERGY MEGATRON™ H7493942824500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729985723), received between Jun 13, 2023 and Apr 28, 2026 — classified as 5 injuries, 2 malfunctions.

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

• InjuryApr 28, 2026Fracture

  IT WAS REPORTED VIA USER MEDWATCH MW5184787 THAT STENT FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE STENT WAS ADVANCED THROUGH THE VESSEL; HOWEVER, WHEN PULLING OUT THE STENT, IT BROKE IN THE VESSEL. A SNARE DEVICE WAS USED TO SUCCESSFULLY RETRIEVE THE DETACHED SEGMENT. NO PATIENT COMPLICATIONS WERE REPORTED. NOT FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015212 ↗
• InjuryMar 30, 2026Break; Failure to Deflate

  IT WAS REPORTED THAT DEVICE ISSUES OCCURRED REQUIRING ADDITIONAL INTERVENTION.THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY. AFTER PLACEMENT OF TWO GUIDE CATHETERS AND TWO GUIDEWIRES, PRE-DILATATION WAS PERFORMED USING MULTIPLE BALLOONS. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) WAS INTRODUCED BUT AFTER THE STENT WAS IMPLANTED, DEFLATION ISSUES OCCURRED, MULTIPLE NEGATIVE DEFLATIONS WERE PERFORMED, HOWEVER, WHEN REMOVING THE CATHETER FROM THE STENT, THE CATHETER BROKE OFF INSIDE THE PATIENT AND HAD TO BE RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715424 ↗
• MalfunctionDec 9, 2025Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component; Entrapment of Device; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND BALLOON DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED WITHOUT DIFFICULTY. DURING WITHDRAWAL, AS THE BALLOON WAS PULLED BACK INTO THE GUIDE, IT BECAME STUCK IN THE DISTAL GUIDE. AS THE PHYSICIAN BEGAN TO PULL THE DEVICE OUT, THE BALLOON WAS SEPARATED FROM THE DELIVERY SHAFT, REMAINING IN THE GUIDE CATHETER. A TRAPPING BALLOON WAS USED TO SECURE THE DISLODGED BALLOON IN THE GUIDE CATHETER, AND THE GUIDE CATHETER WAS SUCCESSFULLY REMOVED ALONG WITH THE DISLODGED BALLOON. THERE WERE NO PATIENT COMPLICATIONS WHILE REMOVING THE DISLODGE BALLOON AND THE CASE WAS COMPLETED WITH SUCCESS. PATIENT WAS FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS DEFLATED PRIOR TO THE INITIAL ATTEMPT TO WITHDRAW THE DEVICE WAS ABOUT 2-3 SECONDS AND WAS FULLY DEPLOYED/EXPANDED DURING STENT DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759223 ↗
• InjurySep 9, 2024Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON DETACHMENT OCCURRED. THE 5.00 X 24MM SYNERGY MEGATRON DRUG ELUTING STENT WAS SELECTED FOR USE. DURING DEPLOYMENT OF THE STENT, THE BALLOON RUPTURED AND SHEARED OFF THE CATHETER AND REMAINED IN THE PATIENT. THE BALLOON WAS RETRIEVED PERCUTANEOUSLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20170511 ↗
• InjuryAug 14, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH. AFTER PRE-DILATATION OF THE VEIN GRAFT, A 5.00 X 24 MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE INITIAL INFLATION AT 14 ATMOSPHERES, THE STENT WAS SUCCESSFULLY DEPLOYED BUT THE STENT BALLOON RUPTURED. DURING REMOVAL OF THE BALLOON, APPROXIMATELY 20 CM OF THE DISTAL PORTION OF THE STENT DELIVERY SYSTEM BROKE AND SEPARATED. THE PHYSICIAN THEN INTRODUCED A SECOND NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE ALONG WITH A 3.00 X 12 MM NC EMERGE BALLOON CATHETER AND WAS ABLE TO INFLATE THE BALLOON ENOUGH TO PIN THE BROKEN SHAFT AND REMOVE EVERYTHING FROM THE PATIENT. SHORTLY AFTERWARD, THE PATIENT MAY HAVE SUFFERED A STROKE. THE PATIENT HAS SINCE RECOVERED WITH NO FURTHER ISSUES AND IS CURRENTLY STABLE.

  Patient problems: Ischemia Stroke

  MAUDE report 19988507 ↗
• MalfunctionJun 20, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SHAFT SEPARATION OCCURRED. A TRANSCATHETER AORTIC VALVE REPLACEMENT WAS BEING PERFORMED USING A SYNERGY MEGATRON MR US 5.00 X 24MM AS A PART OF TREATMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE BALLOON WAS UNABLE TO COME BACK INTO THE GUIDE. WHEN ATTEMPTING TO RETRIEVE THE DEVICE FROM THE PATIENT, THE BALLOON BROKE OFF THE DELIVERY SYSTEM INTO THE PATIENT. THE BALLOON WAS RETRIEVED FROM THE PATIENT USING A SNARE. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166827 ↗
• InjuryJun 13, 2023Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE, REMOVAL DIFFICULTIES AND VESSEL DISSECTION OCCURRED. THE STENOSED TARGET LESION WAS LESS THAN 60% LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. AFTER THE NON-BOSTON SCIENTIFIC GUIDEWIRE CROSSED THE LESION, A 5.00 X 24MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS THEN PLACED FOR TREATMENT. IT WAS NOTED THAT PHYSICIAN AWARE THAT THE BALLOON PLATFORM WAS A LARGER THAN THE NORMAL BALLOON OF WORKHORSE STENTS. SO, THE DEVICES WERE REMOVED ALL AT ONCE, HOWEVER, DURING REMOVAL, THE TIP OF THE STENT BALLOON RUPTURED AT 24 ATMOSPHERES IN 16 SECONDS AND WOULD NOT COME OUT FROM THE SHEATH. IT WAS NOTED THAT THE PHYSICIAN DID NOT GIVE THE BALLOON TIME ENOUGH TO DEFLATE BEFORE PULLING BACK INTO THE GUIDE CATHETER. HENCE, RESULTED INTO DISSECTION OF THE RIGHT COMMON ILIAC ARTERY. THE PROCEDURE WAS COMPETED SUCCESSFULLY, AND NO FURTHER PATIENT COMPLICATIONS REPORTED. THE PATIENT STATUS WAS STABLE POST-PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 17119503 ↗