SYNERGY™ XD H7493941824400Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729981145), received between Nov 30, 2020 and Nov 12, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 12, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 4.00 X 24 MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER THE ATTEMPT TO CROSS THE LESION, DURING WHICH SIGNIFICANT FORCE WAS APPLIED, THE STENT DELIVERY SYSTEM WAS REMOVED BECAUSE THE LESION COULD NOT BE CROSSED. UPON REMOVAL, THE SHAFT OF THE STENT DELIVERY SYSTEM FRACTURED AND DETACHED FROM THE DISTAL THREE-FOURTHS OF THE SDS. THE DEVICE WAS COMPLETELY REMOVED AND NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SYNERGY DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23534573 ↗
• MalfunctionJan 16, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 3.5 NC BALLOON CATHETER. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, UPON REMOVAL OF THE STENT, IT WAS NOTICED THAT THE SHAFT WAS BROKEN. THE DEVICE WAS COMPLETELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173298 ↗
• InjuryNov 20, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED AND RESULTED IN AN UNRETRIEVED DEVICE FRAGMENT. A 4.00 X 24 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, A SHAFT BREAK OCCURRED. THE DEVICE WAS PARTIALLY EXPLANTED; HOWEVER, A PORTION REMAINS IMPLANTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS OVER 50% STENOSED, WITH A 90-DEGREE BEND LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT CIRCUMFLEX ARTERY (LCX). THE SHAFT BREAK OCCURRED AT THE DISTAL SECTION OF THE DEVICE AND A SNARE WAS USED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE DEVICE FRAGMENT. A STENT WAS THEN PLACED OVER THE DEVICE FRAGMENT. THIS RESULTED IN A LCX DISSECTION, WHICH COULD NOT BE RETRIEVED OR REOPENED.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 20739262 ↗
• MalfunctionJul 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR USED. HOWEVER, WHEN THE STENT WAS PULLED OUT OF THE PACKAGING, THE STENT DISLODGED FROM THE BALLOON. A NEW 4.00X24 SYNERGY DES WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19731465 ↗
• MalfunctionJan 26, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 24MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE PORTION OF THE SHAFT IMMEDIATELY NEXT TO THE HUB OUTSIDE OF THE HOOP WAS SLIGHTLY KINKED; AN ATTEMPT WAS MADE TO STRAIGHTEN IT, BUT IT SNAPPED OFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18585961 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated; Device-Device Incompatibility; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT DETACHED FROM THE BALLOON AND STAYED IN THE 6F GUIDEZILLA GUIDE EXTENSION CATHETER WHEN IT WAS ADVANCED. BOTH DEVICES WERE REMOVED FROM THE PATIENT SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787527 ↗
• MalfunctionDec 18, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT CORONARY STENTING FOR ST-ELEVATION MYOCARDIAL INFARCTION. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE STENT THROUGH TUOHY AND GUIDE CATHETER, THE PROXIMAL DELIVERY SHAFT GOT KINKED AND BROKE COMPLETELY. THE DEVICE WAS REMOVED FROM THE GUIDE CATHETER OVER WIRE AND ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16001560 ↗
• MalfunctionJun 13, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION. IT WAS ALSO NOTICED THAT THE STENT WAS DAMAGED AND THE WHOLE SYSTEM WAS PULLED AND HAD TO START OVER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14681813 ↗
• MalfunctionJun 13, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, IT WAS FOUND OUT THAT THE STENT WAS FRAYED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672912 ↗
• MalfunctionApr 20, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE DEVICE HAD DIFFICULTY ADVANCING THROUGH THE GUIDEZILLA. THE PHYSICIAN HAD TO TAKE THE STENT OUT DUE TO POSSIBLE DAMAGE. SINCE THE GUIDEZILLA HAD NO DAMAGE, IT HAS BEEN USED THROUGHOUT THE CASE WITH A NEW SYNERGY STENT AND BALLOONS AND THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164443 ↗
• MalfunctionFeb 14, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, HOWEVER, DURING PROCEDURE WHILE TRYING TO CROSS THE LESION THE SHAFT BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13530274 ↗
• MalfunctionNov 8, 2021Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND STENT MOVE ON BALLOON OCCURRED. THE PATIENT HAD PREVIOUSLY IMPLANTED STENT IN THE LESION WITH IN-STENT RESTENOSIS. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO PUT ANOTHER LAYER OF STENT IN THE LESION. HOWEVER, UPON ADVANCING, IT GOT CAUGHT ON THE STRUT OF PREVIOUSLY IMPLANTED STENT AND IT LENGTHENED THE STENT. THE DEVICE WAS REMOVED OVER THE WIRE AND THE STENT WAS STILL ON THE BALLOON AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775271 ↗
• InjuryOct 26, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DETACHED FROM THE BALLOON AND WAS DISLODGED INSIDE THE PATIENT. THE PHYSICIAN TRIED TO REWIRE AND REMOVE THE DETACHED STENT BUT REMOVAL WAS UNSUCCESSFUL. THE DISLODGED STENT WAS THEN CRUSHED WITHIN THE LESION BY ADDITIONAL STENTING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DOING WELL POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698166 ↗
• InjuryJul 22, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN AN ANGULATED RIGHT CORONARY ARTERY WITH A RECENTLY PLACED STENT IN SITU. AFTER A 6FR GUIDEZILLA II WAS IN POSITION, A 4.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AND BROKE HALFWAY OUT OF THE GUIDEZILLA. SNARE WAS USED IN ADDITION TO PASSING A BALLOON DISTAL AND PULLING PIECE OF STENT TO THE OSTIUM, WHERE IT WAS SNARED AGAIN AND REMOVED FROM THE PATIENT'S BODY. THERE WAS SIGNIFICANT DELAY IN CASE, BUT NO HARM TO PATIENT. THE PROCEDURE WAS ABORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215499 ↗
• MalfunctionNov 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A SAPHENOUS VEIN GRAFT (SVG) PROCEDURE WAS PERFORMED ON A 60 TO 70% STENOSED TARGET LESION, LOCATED IN THE MILDLY TORTUOUS DISTAL RIGHT CORONARY ARTERY (RCA). A 4.00 X 24MM SYNERGY XD WAS USED FOR TREATMENT. IT WAS NOTED THAT A NON BOSTON SCIENTIFIC EMBOLIC PROTECTION WIRE WAS NOT CLOSED INTO THE SHEATH PRIOR TO RETRACTION. THE NON BOSTON SCIENTIFIC FILTER BASKET CAUGHT ONTO THE SYNERGY XD STENT STRUTS, WHICH DEFORMED AND DAMAGED THE STENT. AN ATTEMPT TO REWIRE THROUGH THE STENT WAS PERFORMED, BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED AND THE PATIENT HAD GOOD FLOW. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT AND THE PATIENT WAS REPORTED TO BE STABLE UPON COMPLETION OF THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10919678 ↗