SYNERGY MEGATRON™ H7493942816500Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729985648), received between Feb 14, 2022 and Mar 30, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. FOLLOWING NORMAL PREPARATION, A 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE STENT BALLOON WAS INFLATED AT NOMINAL PRESSURE, THE BALLOON WAS DEFLATED; HOWEVER, IT GOT STUCK WITHIN THE STENT AND HAD TO PULL HARD TO GET THE BALLOON OUT. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE AND PULL THE DEVICE, BUT THE BALLOON REMAINED STUCK IN THE STENT. ADDITIONAL FORCE WAS APPLIED AND THE GUIDE CATHETER WAS PULLED OUT ALONG WITH THE BALLOON. A NEW GUIDE CATHETER AND AN ALTERNATE DEVICE WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED. THE STENT WAS SUCCESSFULLY DEPLOYED, AND THE BALLOON DEFLATED SLOWLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731803 ↗
• InjuryMar 24, 2026Material Rupture; Failure to Unfold or Unwrap; Device Dislodged or Dislocated

  IT WAS REPORTED VIS MEDSUN (b)(4) THAT BALLOON RUPTURE OCCURRED REQUIRING ADDITIONAL SURGERY.THE PATIENT PRESENTED FOR A RIGHT HEART PERCUTANEOUS, PATENT DUCTUS ARTERIOSUS, STENTING PROCEDURE. THE 5.00 X 16MM SYNERGY MEGATRON WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT DELIVERY SYSTEM BALLOON RUPTURED RESULTING IN A LACK OF DEPLOYMENT OF THE STENT. THE STENT REMAINED IM THE LEFT SUBCLAVIAN ARTERY. THE PATIENT BECAME SEVERELY CYANOTIC AND WAS EMERGENTLY TRANSFERRED TO THE OPERATING ROOM FOR LIFE SAVING INTERVENTION. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED STENT AND FOR VASCULAR REP.

  Patient problems: Hypoxia

  MAUDE report 24675410 ↗
• InjuryMar 3, 2026

  THE PT WAS ADMITTED TO HOSPITAL CARDIAC CATH LAB FOR A RIGHT HEART PERCUTANEOUS PROCEDURE. DURING THE PROCEDURE, THE BALLOON RUPTURED WITH RESULTING LACK OF DEPLOYMENT OF THE STENT, WHICH REMAINED IN THE LEFT SUBCLAVIAN ARTERY. THE PT BECAME SEVERELY CYANOTIC AND WAS EMERGENTLY TRANSFERRED TO THE OPERATING ROOM FOR LIFE SAVING INTERVENTION. PT BROUGHT BACK TO OR ON [REDACTED] FOR REMOVAL OF THE RETAINED STENT AND VASCULAR REPAIR.

  Patient problems: Cyanosis

  MAUDE report 24495652 ↗
• MalfunctionFeb 24, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. A 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS DEPLOYED WITHOUT ANY ISSUES FOR TREATMENT. POST-DEPLOYMENT, THE BALLOON WAS DEFLATED FOR AT LEAST 5 SECONDS AND NO CONTRAST WAS NOTED IN THE BALLOON. HOWEVER, THE STENT BALLOON GOT STUCK ON THE TIP OF THE 6F GUIDE CATHETER WHEN TRYING TO REMOVE IT AND BROKE OFF. THE DEVICE WAS REMOVED WITHOUT ANY PATIENT COMPLICATIONS AND THE CASE ENDED WELL WITH NO DAMAGE TO THE DEPLOYED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454141 ↗
• InjuryApr 12, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE BALLOON BECAME STUCK IN THE STENT STRUTS. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND CALCIFIED LEFT MAIN (LM) ARTERY. A 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. FOLLOWING STENT DEPLOYMENT, THE BALLOON WAS DEFLATED AND PULLED BACK PART WAY TO POST-DILATE THE PROXIMAL EDGE IN THE LM AND USE THE PROXIMAL BALLOON AS A PROXIMAL OPTIMIZATION TECHNIQUE (POT) TECHNIQUE. THE BALLOON WAS DEFLATED NORMALLY BUT GOT CAUGHT ON THE STENT STRUTS AS IT WAS DEFLATED AND BECAME STUCK. A 30MM BALLOON WAS INSERTED IN THE GUIDE ALONGSIDE THE STENT SHAFT AND PINNED THE STENT SHAFT AGAINST THE INNER GUIDE. THE SYSTEM WAS THEN PULLED OUT SUCCESSFULLY. THE STENT WAS NOT AFFECTED AND POST-DILATATION WAS PERFORMED WITH A NEW BALLOON TO COMPLETE THE PROCEDURE. THE BALLOON WAS REMOVED IN A FULLY DEFLATED STATE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098579 ↗
• MalfunctionJan 23, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN RENAL ARTERY. A 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY. HOWEVER, UPON REMOVAL OF THE BALLOON, IT WAS STUCK AND WAS DIFFICULT TO REMOVE FROM THE STENT. THE DEVICE WAS PULLED AND WAS REMOVED INTACT FROM THE PATIENT TOGETHER WITH THE WIRE AND GUIDE CATHETER. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564980 ↗
• InjuryJun 29, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK, REMOVAL DIFFICULTIES, AND ADDITIONAL SURGERY OCCURRED. THE PATIENT WAS PRESENTED WITH RENAL DISEASE AND UNDERWENT RENAL ANGIOPLASTY. FOLLOWING PLACEMENT OF A 6FR SHEATH. A 5.00 X 16MM SYNERGY MEGATRON STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THERE WAS DIFFICULTY PULLING THE BALLOON INTO THE GUIDE AND THE STENT BALLOON BROKE OFF IN THE PATIENT'S BRACHIAL ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE THE DEVICE BUT COULD NOT CAPTURE IT. VASCULAR SURGERY CUTDOWN WAS DONE TO REMOVE THE MEGATRON STENT. THE PROCEDURE WAS ABORTED. THERE WERE NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT HAD FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233253 ↗
• MalfunctionFeb 8, 2023Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.00 X 16M SYNERGY MEGATRON DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE BALLOON RUPTURED. THE DEVICE WAS PULLED OUT FROM THE GUIDE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330144 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND BALLOON DEFLATION FAILURE OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A 5.00 X 8MM SYNERGY MEGATRON DRUG-ELUTING STENT (DES) AND A 5.00X16 SYNERGY MEGATRON DES WERE DEPLOYED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BALLOONS WERE STICKY AND STUCK IN THE LESION WHERE THE STENTS WERE IMPLANTED. IT WAS ALSO NOTED THAT THE BALLOONS WERE NOT DEFLATING PROPERLY AND ONE OF THE BALLOONS GOT STUCK AND COULD NOT PASS THROUGH THE GUIDE CATHETER. THE PHYSICIAN HAD TO PULL NEGATIVE AND DEFLATE THE BALLOONS MULTIPLE TIMES AND HAD TO TAKE THE BALLOONS AND GUIDE CATHETER SYSTEM OUT, AS A WHOLE UNIT. BOTH STENTS WERE IMPLANTED INTO THE PATIENT AND THE PROCEDURE WAS COMPLETED. NO HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16137511 ↗
• InjuryOct 28, 2022Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND STENT DAMAGE POST DEPLOYMENT OCCURRED. THE 80-95% STENOSED TARGET LESION WAS LOCATED IN MILD-NON TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN ARTERY. INTRAVENOUS ULTRASOUND (IVUS) WAS DONE, AND PRE-DILATATION WAS PERFORMED OF THE TARGET LESION. A 5.00 X 16MM SYNERGY MEGATRON STENT WAS UNPACKED AND PREPPED WITH ONE NEGATIVE PREP. THE SYNERGY MEGATRON STENT WAS THEN ADVANCED FOR TREATMENT AND FEW ANGIOGRAPHIES WAS DONE TO CONFIRM PROPER POSITION. THE PHYSICIAN INFLATED THE DEVICE WITH A 70 SALINE AND 30 CONTRAST MIXTURE TO 16 ATMOSPHERES (ATMS) FOR 25 SECONDS AND DIALED DOWN THE ATMS FOR 5-10 SECONDS TO ZERO AND PULLED NEGATIVE. DURING REMOVAL OF THE STENT DELIVERY SYSTEM (SDS) WITH INFLATION DEVICE ON NEGATIVE, THE SDS WOULD NOT PASS THROUGH THE 7FR. NON- BOSTON SCIENTIFIC GUIDE CATHETER AND IT WAS STUCK. THE PHYSICIAN TRIED TO LIGHTLY TUG ON THE SDS SYSTEM TO RELEASE AND THE BALLOON WOULD NOT RETRACT INTO THE GUIDE CATHETER. THE BALLOON OF THE SDS WAS TRIED TO INFLATE TO 3-6 ATM AND SLOWLY CAME DOWN BUT STILL THE BALLOON DID NOT WRAP WELL AS WELL AS RETRACT INTO THE GUIDE. THE PHYSICIAN THEN REMOVED THE ENTIRE GUIDE CATHETER, SAMURAI WIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15691945 ↗
• MalfunctionOct 5, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A SYNERGY MEGATRON 5.00 X 16MM BALLOON EXPANDABLE STENT WAS SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION PROCEDURE. THE SYNERGY STENT WAS IMPLANTED AND THE DELIVERY SHAFT BROKE DURING WITHDRAWAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544372 ↗
• MalfunctionAug 3, 2022Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. A 70% TO 80% STENOSED TARGET LESION WAS LOCATED IN A NONE TORTUOUS AND MINIMALLY CALCIFIED LEFT MAIN(LM) ARTERY AND PROXIMAL ANTERIOR DESCENDING ARTERY (LAD). A TWO 5.00 X 16MM SYNERGY MEGATRON DRUG-ELUTING STENT WERE SELECTED FOR USE IN THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED AND THE LESION PRE DILATED WITH EMERGE BALLOON. A FIRST SYNERGY MEGATRON WAS DEPLOYED IN LAD, THEN A SECOND SYNERGY MEGATRON STENT USED FOR LM. AFTER DEPLOYING STENT 16 ATMOSPHERE, PHYSICIAN PULLED STENT BACK TO FLARE AT OSTIUM AND FELT THE BALLOON GOT STUCK ON PROXIMAL STENT STRUT. AFTER MULTIPLE ATTEMPTS TO RE-INFLATING BALLOON AT 18 ATMOSPHERE, ADVANCING GUIDE CATHETER TO STENT BALLOON AND TRY TO USE AS SUPPORT, AND IT WAS UNSUCCESSFUL TO GET THE BALLOON LOOSE FROM STENT. THEN, THE PHYSICIAN DECIDED TO PULL AND THE STENT STAYED IN PLACE. AFTER GETTING STENT LOOSE WAS STILL UNABLE TO GET BACK IN GUIDE CATHETER, SO, THE PHYSICIAN REMOVED THE GUIDE CATHETER, GUIDEWIRE AND THE BALLOON AS ONE PIECE BY PULLING THE GUIDE CATHETER WITH IT. THE BALLOON REMOVED IN FULLY DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15160662 ↗
• MalfunctionMay 31, 2022Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON AN 85% STENOSED MID RIGHT CORONARY ARTERY (RCA). A 5.00 X 16MM SYNERGY MEGATRON WAS SELECTED FOR TREATMENT DUE TO THE VESSEL BEING 5.5MM LARGE. THE LESION WAS PREDILATED AND THE STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED AT 11 ATMOSPHERES FOR 20 SECONDS IN THE RCA. FOLLOWING STENT DEPLOYMENT, THE STENT BALLOON WAS PULLED AT A DOUBLE NEGATIVE PRESSURE, AND THE BALLOON WAS ATTEMPTED TO BE REMOVED. HOWEVER, THE BALLOON GOT HUNG UP IN THE PROXIMAL PART OF THE 6FR JR4 NON BOSTON SCIENTIFIC GUIDE CATHETER. ANOTHER ATTEMPT TO PULL NEGATIVE AND PULL THE BALLOON OUT WITH GREAT FORCE WAS ATTEMPTED, BUT THE SHAFT OF THE BALLOON BROKE. IT WAS NOTED THAT VACUUM WAS HELD DURING WITHDRAWAL UNTIL THE FRACTURE OCCURRED. IT WAS NOTED THAT THE TARGET LESION WAS NOT TORTUOUS, BUT THE RIGHT SUBCLAVIAN VESSEL THAT THE USER WAS WORKING THROUGH WAS VERY TORTUOUS. EVERYTHING (GUIDE CATHETER, WIRE, AND BALLOON) WAS REMOVED OUT OF THE PATIENT. IT WAS NOTICED THAT THE BALLOON WAS STILL STUCK IN THE TIP OF THE GUIDE, AND THAT THE BALLOON WAS FULLY DEFLATED. THE SHAFT BREAK WAS NOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14548633 ↗
• InjuryFeb 14, 2022Deflation Problem; Difficult to Remove; Material Integrity Problem; Deflation Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO DEFLATE AND A VESSEL OCCLUSION OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT MAIN LESION. A 5.00 X 16MM SYNERGY MEGATRON WAS SELECTED FOR USE IN THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE. THERE A SIGNIFICANT BEND INVOLVED IN THE LESION. THE LESION PRE DILATED WITH 1.5,2.5 AND 3.0 NC EMERGE BALLOON. THERE WAS NO DIFFICULTY ADVANCING THE DEVICE OVER A NON BOSTON SCIENTIFIC WIRE AND THROUGH THE GUIDE CATHETER. THE SYNERGY MEGATRON STENT HAD DELIVERED THROUGH THE STRUTS OF A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) VALVE. THE SYNERGY WAS DELIVERED TO THE LESION SITE AND THE BALLOON INFLATED ONCE AT 12 ATMOSPHERES FOR 10 SECONDS. AFTER THE STENT IMPLANTED, THE PHYSICIAN ATTEMPTED TO DEFLATE THE BALLOON FOR 20 SECONDS, BUT THE BALLOON WAS UNABLE TO DEFLATE, RETRIEVE AND VESSEL OCCLUSION OCCURRED. THEN, THE PHYSICIAN CUT THE BACK END OF THE STENT CATHETER AND DELIVER A GUIDE EXTENSION CATHETER OVER IT IN ORDER TO RETRIEVE THE BALLOON. THE DEVICE WAS REMOVED BY SHEATHING IT INSIDE OF A GUIDE EXTENSION CATHETER AND THE BALLOON WAS REMOVED IN PARTIALLY INFLATED. IT WA

  Patient problems: Obstruction/Occlusion

  MAUDE report 13523189 ↗