SYNERGY™ XD H7493941820250Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08714729980810), received between Dec 23, 2020 and Mar 9, 2026 — classified as 6 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. DURING PREPARATION, WHEN THE STENT WAS LOADED ONTO THE WIRE, THE STENT SEPARATED FROM THE BALLOON WITHOUT THE BALLOON BEING INFLATED. THE STENT WAS NOT INSERTED INTO THE BODY. ANOTHER SYNERGY STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548003 ↗
• InjuryFeb 11, 2026Device Damaged by Another Device; Migration

  IT WAS REPORTED THAT A STENT MIGRATION OCCURRED. AN OPTICROSS HD IMAGING CATHETER WAS SELECTED FOR INTRAVASCULAR ULTRASOUND EXAMINATION. AFTER PLACEMENT OF THE SYNERGY XD 2.5 X 20 STENT, IVUS EXAMINATION WAS PERFORMED, AND IT WAS NOTED THAT THE IVUS CATHETER BECAME STUCK WITHIN THE STENT. IT COULD NEITHER BE ADVANCED NOR WITHDRAWN; THEREFORE, THE PROXIMAL PORTION WAS CUT, AND THE IMAGING CORE WAS REMOVED, AND AN 0.018-INCH GUIDEWIRE WAS INSERTED. THE ENTRAPMENT WAS THEN RESOLVED, BUT THE STENT HAD MIGRATED. IT WAS NOTED THAT DURING THE PROCEDURE THE IVUS CATHETER WAS KINKED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24318259 ↗
• InjuryOct 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, RESULTING IN AN ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER BALLOONING THE OLD STENT WITH ISR MULTIPLE TIMES, THE PHYSICIAN ATTEMPTED TO DELIVER AND DEPLOY A 2.50 X 20 MM SYNERGY? XD DRUG-ELUTING STENT (DES) DISTALLY TO COVER A DISSECTION. A NON-BOSTON SCIENTIFIC (BSC) WIRE, A 6F NON-BSC GUIDE EXTENSION CATHETER, AND A NON-BSC GUIDE WIRE WERE IN PLACE WHEN THE STENT BECAME DISLODGED IN THE PROXIMAL LAD, PROXIMAL TO THE PREVIOUSLY IMPLANTED STENT. A 1.00 X 10 MM BALLOON CATHETER WAS INSERTED IN AN ATTEMPT TO RECAPTURE THE DISLODGED STENT INTO THE GUIDE CATHETER BY INFLATING THE BALLOON DISTAL TO THE STENT AND PULLING BACK. HOWEVER, THIS MANEUVER WAS UNSUCCESSFUL. AS THE STENT COULD NOT BE RETRIEVED, IT WAS ULTIMATELY DEPLOYED IN PLACE, AND MULTIPLE BALLOONS WERE USED TO DILATE THE STENT UP TO 3.50 MM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23408025 ↗
• MalfunctionApr 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 2.50 X 20 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT BROKE WHEN THE PHYSICIAN ATTEMPTED TO USE IT. NO FURTHER ISSUES AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21741080 ↗
• MalfunctionFeb 13, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, WHEN THE DEVICE WAS PULLED FROM HOOP, THE MID SHAFT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695981 ↗
• MalfunctionNov 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 20 MM SYNERGY XD WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT CAME OFF OF THE BALLOON WHILE INSIDE THE GUIDE CATHETER. THERE WERE NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220818 ↗
• MalfunctionFeb 22, 2023Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated; Failure to Advance; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR CORONARY ARTERY DISEASE (CAD). THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED PROXIMAL RIGHT CORONARY ARTERY (RCA). A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS DELIVERED THROUGH THE GUIDE INTO THE PROXIMAL RCA LESION WHERE IT INTERACTED WITH A PREVIOUSLY PLACED STENT. FRICTION WAS ENCOUNTERED WHICH RESULTED IN FAILURE TO BE DELIVERED MORE DISTAL IN THE RCA. UPON REMOVAL OF THE DEVICE, THE STENT DISLODGED FROM THE BALLOON AT THE PROXIMAL RCA LESION. THE STENT DELIVERY BALLOON WAS REMOVED, AND ANOTHER NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS USED TO ENTER IN THE UNDEREMPLOYED STENT. SUBSEQUENTLY, A 2.0 MM BALLOON AND A 3.0 MM NC BALLOON WERE USED TO FULLY EXPAND THE STENT IN PROXIMAL RCA LESION WITHOUT ANY ISSUE AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421244 ↗
• MalfunctionFeb 14, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CIRCUMFLEX ARTERY. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING PREPARATION, THE PROXIMAL PART OF THE SHAFT BROKE WHEN TAKING THE CATHETER OUT OF THE SHELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16371570 ↗
• InjuryAug 15, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT MEDICAL PROBLEM OCCURRED. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE INABILITY TO CROSS THE LESION CAUSED A SIGNIFICANT DELAY TO THE PROCEDURE THAT RESULTED IN AN ADVERSE PATIENT EVENT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 15225131 ↗
• MalfunctionJun 22, 2022Break; Failure to Advance; Device Dislodged or Dislocated; Break; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE DETACHMENT AND STENT DISLODGEMENT OCCURRED. THE 2.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE TARGET LESION. THE DELIVERY SYSTEM BROKE INTO TWO PIECES AND THE STENT FELL OFF. THERE WAS NO ADVERSE PATIENT EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14777443 ↗
• InjuryApr 26, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. FOLLOWING PRE-DILATATION WITH A 2.5 X 20 BALLOON, A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. INTRAVASCULAR LITHOTRIPSY (IVL) WAS USED TO ADVANCE THE STENT BUT IT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED UNDEPLOYED AND IT WAS NOTED THAT A STENT STRUT WAS STICKING OUT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation of Vessels

  MAUDE report 14214998 ↗
• InjuryApr 4, 2022Break; Deflation Problem; Difficult to Remove; Break; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED WHICH LED TO PATIENT COMPLICATIONS AND A SHAFT BREAK. THE PATIENT PRESENTED NOT DOING WELL AND ALREADY IN CARDIAC SHOCK. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED OBTUSE MARGINAL (OM) BRANCH. THE PHYSICIAN HAD TO STENT THE LESION PROXIMAL TO DISTAL. THE SECOND STENT, A 2.50 X 20MM SYNERGY XD, WAS DEPLOYED TO AN UNKNOWN PRESSURE BELOW RATED BURST PRESSURE. POST STENT DEPLOYMENT, THE STENT DELIVERY SYSTEM (SDS) BALLOON WOULD NOT DEFLATE AND WAS STUCK IN THE ARTERY. MORE THAN 10 MINUTES WAS SPENT TRYING TO DEFLATE THE BALLOON AND WHILE THE BALLOON REMAINED INFLATED, THE PATIENT EXPERIENCED CHEST PAIN AND CODED. MULTIPLE STIFF WIRES AND SNARES WERE USED IN AN ATTEMPT TO POP THE BALLOON. WHEN THESE ATTEMPTS WERE UNSUCCESSFUL, THE WIRE AND SDS WERE PULLED, BUT BOTH THE WIRE AND SDS SHAFT SNAPPED; THE SDS SHAFT BROKE RIGHT BEFORE THE PROXIMAL MARKERBAND. THE WIRE FRAGMENTS WERE ABLE TO BE SNARED BUT SOME OF THE SDS REMAINED INSIDE THE PATIENT CAUSING THE OM BRANCH TO OCCLUDE. BECAUSE THE PATIENT HAD PRESENTED FOR THE PROCEDURE ALREADY IN CARDIAC SHOCK, SURGERY TO REMOVE THE DEVICE

  Patient problems: Chest Pain; Diminished Pulse Pressure; Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 13999379 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVAL OF THE STENT FROM THE STERILE LOOP, IT WAS BROKEN IN HALF AT THE MID SHAFT. THE STENT WAS NEVER USED AND 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 13503404 ↗
• MalfunctionNov 30, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE EVENT OCCURRED. A 2.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND AN ADVERSE DELAY OCCURRED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE COMPLAINT WAS FURTHER EVALUATED, AND ANOTHER DEVICE WAS ABLE TO CROSS THE LESION TO COMPLETE THE PROCEDURE. THE REPORTED INFORMATION DOES NOT MEET CRITERIA OF A SERIOUS INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12902325 ↗
• InjuryJul 24, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE LESION WAS PREDILATED. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. PHYSICIAN ATTEMPTED TO REMOVE STENT BEFORE EXPANDING TO ADMINISTER ADDITIONAL PRETREATMENTS. DURING THE STENT REMOVAL PROCESS STENT STRUTS GOT CAUGHT IN A CALCIUM NODULE. STENT SUCCESSFULLY REMOVED BUT BECAME MANGLED IN THE PROCESS. ADDITIONAL IMAGING SHOWED DISSECTION IN PRETREATED ARTERY. THE DISSECTION WAS FLOW LIMITING. ADDITIONAL BALLOON ANGIOPLASTY AND REATTEMPT TO STENT RESOLVED ALL ISSUES. CASE WAS SUCCESSFUL AND PATIENT RECOVERED WELL.

  Patient problems: Vascular Dissection

  MAUDE report 12222619 ↗
• MalfunctionJun 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054810 ↗
• MalfunctionApr 29, 2021Positioning Failure; Difficult to Remove; Material Deformation; Positioning Failure; Difficult to Remove; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A DIAGONAL BRANCH CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 2.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT BALLOON WAS INFLATED AT 11 ATMOSPHERES, THE STENT NEVER DEPLOYED OFF OF THE BALLOON. UPON REMOVAL, IT WAS OBSERVED THAT THE STENT EDGE WAS FLARED AND COULD NOT BE PULLED THROUGH THE GUIDE CATHETER. THE PHYSICIAN HAD TO REMOVE EVERYTHING AS A UNIT. THE BALLOON WAS FULLY DEFLATED WHEN REMOVED. THE PROCEDURE WAS COMPLETED USING ALTERNATE METHOD OR DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11750899 ↗
• MalfunctionFeb 26, 2021Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE DEVICE WOULD NOT LOAD ONTO THE WIRE AND THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT IT WAS THE STENT STRUT ITSELF THAT GOT LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384810 ↗
• MalfunctionJan 22, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON TORTUOUS SAPHENOUS VEIN GRAFT (SVG) TO OBTUSE MARGINAL (OM) BRANCH. A 2.50 X 20MM SYNERGY XD STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE MID AND DISTAL SHAFTS SNAPPED WITH VERY LITTLE FORWARD PRESSURE. THE PHYSICIAN WAS NOT PUSHING IN TO A BARRIER WHEN THE SYSTEM SNAPPED. THE DEVICE WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.50 X 20 MM SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE VALVE WAS FULLY OPENED TO ALLOW EASY PASSAGE OF THE DEVICE AND THERE WAS NO RESISTANCE ENCOUNTERED AT ANY STAGE. THE SHAFT SNAPPED BEFORE ANY KIND OF ATTEMPT TO STRAIGHTEN A KINKED/BENT SHAFT WERE IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11216334 ↗
• MalfunctionDec 23, 2020Material Deformation; Material Deformation

  REPORTABLE BASED ON ANALYSIS COMPLETED ON 16DEC2020. IT WAS REPORTED THAT A KINK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED ON A PATIENT WITH CORONARY ARTERY DISEASE (CAD). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.50 X 20MM SYNERGY XD STENT WAS OPENED AND PREPPED ACCORDINGLY. THE SYNERGY STENT WAS INSERTED INTO THE TOUHY AND THE DELIVERY SYSTEM WAS THEN ADVANCED, BUT THE DELIVERY SYSTEM SHAFT KINKED IMMEDIATELY. THE KINK OCCURRED MID TO DISTAL ON THE SHAFT. IT WAS NOTED THAT THE DEVICE WAS IN THE GUIDE CATHETER, AND NOT THE PATIENT'S ARTERY. NO RESISTANCE WAS FELT WHILE ADVANCING. THE DEVICE WAS REMOVED INTACT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS RESULTED IN RELATION TO THIS EVENT. HOWEVER, THE DEVICE RETURNED AND ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11064858 ↗