SYNERGY™ XD H7493941838400Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729981176), received between Oct 23, 2020 and Apr 20, 2026 — classified as 5 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCE FOR TREATMENT, BUT IT COULD NOT CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE STENT WAS NOT COMPLETELY SEATED ON DEPLOYMENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931814 ↗
• MalfunctionNov 17, 2025Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. A 4.00 X 38MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON AND WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23572438 ↗
• MalfunctionNov 3, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38MM SYNERGY? XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT WAS OBSERVED TO BE DETACHED FROM THE SHAFT AND WAS UNABLE TO BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DES. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457975 ↗
• MalfunctionSep 15, 2025Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25-AUG-2025. IT WAS REPORTED THAT BALLOON LEAK WAS ENCOUNTERED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE BALLOON WAS INFLATED TO 8 ATMOSPHERES BEFORE DEFLATING IMMEDIATELY. THE STENT WAS OPPOSED TO THE VESSEL WALL ENOUGH TO REMOVE THE BALLOON. THE STENT WAS POST DILATED WITH A NON-COMPLIANT (NC) BALLOON AND PATIENT WAS FINE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED BALLOON TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23057715 ↗
• MalfunctionDec 9, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INSERTION THROUGH A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER, THE STENT WAS COMPLETELY DETACHED FROM THE BALLOON INSIDE THE GUIDE. EVERYTHING WAS REMOVED TOGETHER; THE STENT WAS REMOVED INSIDE THE GUIDE. THE PROCEDURE WAS COMPLETED WITH A NEW GUIDEWIRE AND STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880564 ↗
• MalfunctionDec 2, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING UNPACKING, THE STENT WAS SMASHED AND UN-CLEANLY ATTACHED TO THE BALLOON. A NEW STENT WAS THEN PULLED WITHOUT INCIDENT, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819543 ↗
• MalfunctionAug 27, 2024Material Rupture; Material Rupture

  IT WAS REPORTED VIA USER FACILITY MEDWATCH # 5157457 THAT BALLOON RUPTURE OCCURRED. A 4.00 MM X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS INSERTED INTO PROXIMAL MID RIGHT CORONARY ARTERY (RCA). THE STENT WAS POSITIONED. HOWEVER, THE BALLOON BURST UPON INFLATION FOR STENT DEPLOYMENT AT 20 ATMOSPHERES. THE STENT DELIVERY SYSTEM WAS REMOVED WITH THE BALLOON REMAINING INTACT. A CONTRAST INJECTION TO THE RCA, OBSERVED UNDER FLUOROSCOPY, CONFIRMED THAT THE STENT WAS DEPLOYED IN THE APPROPRIATE LOCATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075233 ↗
• MalfunctionJul 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE PATIENT PRESENTED WITH A CHRONIC TOTAL OCCLUSION OF THE LEFT ANTERIOR DESCENDING ARTERY. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT FRACTURED IN THE BODY OF THE STENT AFTER DEPLOYMENT. THE STENT REMAINED INTACT AROUND THE FRACTURE, AND THERE WAS NO PERFORATION. POST-DILATION WAS PERFORMED, AND IT WAS NOTICED THAT THE SIDE CELL APPEARED ABNORMAL, AS IF IT HAD "BLOWN OUT" ON THE SIDES OF THE CELL. THERE WAS NOTHING DISLODGED OR DETACHED. THE DEVICE WAS NOT REMOVED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767567 ↗
• MalfunctionMay 1, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING INSERTION, THE DEVICE BROKE OFF IN THE GUIDE. ANOTHER STENT WAS OPENED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220604 ↗
• MalfunctionApr 24, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, DURING INSERTION, THE DEVICE BROKE OFF IN THE GUIDE. ANOTHER STENT WAS OPENED, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19174938 ↗
• MalfunctionMar 8, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. A 4.00 X 38MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. UPON OPENING, IT WAS NOTED THAT THE STENT WAS MANGLED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18869581 ↗
• MalfunctionFeb 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG ELUTING STENT (DES) WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE PROCEDURE, THE STENT PARTIALLY SHIFTED ON THE STENT BALLOON PRIOR TO DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18770199 ↗
• MalfunctionJan 23, 2024Break; Difficult to Remove; Difficult to Advance; Material Deformation; Break; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS MID RIGHT CORONARY ARTERY (RCA). TWO STENTS HAD ALREADY BEEN PREVIOUSLY IMPLANTED IN THE PROXIMAL AND MID RCA. A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER WAS ADVANCED TO THE MID RCA AND A 4.00 X 38MM SYNERGY XD DRUG ELUTING STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SDS AND ONLY 30% OF THE STENT WAS ADVANCED OUT OF THE GUIDE EXTENSION CATHETER. IT WAS NOTED ON ANGIO THAT THE STENT HAD AN ACCORDION APPEARANCE, BUT IT WAS NOT KNOWN IF THE UNDEPLOYED STENT HAD GOTTEN CAUGHT ON A STENT STRUT OR IF IT HAD GOTTEN CAUGHT COMING OUT OF THE GUIDE EXTENSION CATHETER. DURING AN ATTEMPT TO REMOVE THE SYNERGY XD, THE DEVICE WOULD NOT GO BACK INTO THE GUIDE EXTENSION CATHETER AND THE STENT DELIVERY SYSTEM (SDS) BROKE. THE DETACHED PORTION OF THE SDS WAS LODGED WELL ENOUGH INTO THE GUIDE EXTENSION CATHETER THAT ALL PIECES WERE ABLE TO BE REMOVED, ALONG WITH THE WIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18564475 ↗
• MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 4.0 X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. BEFORE ENTERING THE BODY, THE STENT CAME OFF THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000451 ↗
• MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 4.0 X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. BEFORE ENTERING THE BODY, THE STENT CAME OFF THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000450 ↗
• MalfunctionOct 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 4.0 X 38 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. BEFORE ENTERING THE BODY, THE STENT CAME OFF THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18000449 ↗
• InjurySep 14, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED VIA USER MEDWATCH MW5120195 THAT MULTIPLE PATIENT ISSUES OCCURRED. ON (B)(6) 2023, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH CHEST PRESSURE AND INCREASING SHORTNESS OF BREATH AND WAS TRANSFERRED TO ANOTHER FACILITY FOR CARDIAC CATHETERIZATION. FILMS REVEALED MULTIVESSEL DISEASE AND THE DECISION WAS MADE TO PROCEED WITH PERCUTANEOUS INTERVENTION OF THE LEFT MAIN (LM)/PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE LEFT DOMINANT PROXIMAL CIRCUMFLEX (CX) ARTERY. THE 90% STENOSED CX WAS TREATED WITH A 3.50 NON-BOSTON SCIENTIFIC (NON-BSC) NON-COMPLAINT (NC) BALLOON, AND PLACEMENT OF A 4.00 X 38 SYNERGY XD STENT. THE STENT WAS POST-DILATED WITH A 4.50 X 12 NON-BSC NC BALLOON AND FINAL FILMS REVEALED GOOD RESULT WITH TIMI III FLOW. THE PATIENT CONTINUED TO DO WELL AND WAS DISCHARGED ON ASPIRIN AND PLAVIX. THE PATIENT REPORTED BEING COMPLIANT WITH THEIR MEDICATIONS. ON (B)(6) 2023, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT WITH INCREASING SHORTNESS OF BREATH AND NO CHEST DISCOMFORT. OVER THE NEXT WEEK THE PATIENT WAS TREATED FOR RESPIRATORY DISTRESS, ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, ACUTE KIDNEY INJURY, AND NON-ST ELEVATION MYOCARDIAL IN

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Myocardial Infarction; Renal Impairment; Respiratory Insufficiency; Thrombosis/Thrombus

  MAUDE report 17750255 ↗
• InjurySep 6, 2023Break; Difficult to Remove; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTIES OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS PERFORMED. THE STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY THROUGH A 6F NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER, THE STENT FAILED TO CROSS THE ENTIRE LESION. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE OUT, BUT THE SHAFT BROKE WITH THE STENT, BALLOON, AND PART OF THE SHAFT STILL ENTRAPPED IN THE CORONARY ARTERY. MULTIPLE UNSUCCESSFUL SNARING ATTEMPTS WERE MADE, SO THE PATIENT WAS SENT FOR OPEN-HEART SURGERY TO RETRIEVE THE BROKEN DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17692486 ↗
• MalfunctionFeb 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STYLET WAS PULLED AND THE STENT DETACHED FROM THE BALLOON. A NEW STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16326464 ↗
• MalfunctionDec 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED. HOWEVER, UPON PULLING THE STENT PROTECTOR, THE STENT CAME WITH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15906432 ↗
• MalfunctionNov 14, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS MID CIRCUMFLEX ARTERY. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION, AND THE PHYSICIAN NOTICED THAT THE STENT APPEARED TO BE PARTIALLY DETACHED FROM THE BALLOON. THE STENT WAS CAREFULLY REMOVED BACK INTO THE GUIDE AND WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788635 ↗
• MalfunctionSep 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED. A 4.00 X 38MM SYNERGY XD STENT BALLOON WAS SELECTED FOR USE. HOWEVER, DURING THE PREPARATION, WHEN PULLING THE STYLET THE STENT CAME OFF THE BALLOON DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411017 ↗
• MalfunctionJul 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM THE PATIENT BODY ALONG WITH THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113847 ↗
• InjuryJun 9, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT AN ADVERSE PATIENT EVENT OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED 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. DESPITE MULTIPLE EFFORTS, NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 14649308 ↗
• MalfunctionJan 3, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. WHEN THE DEVICE WAS PULLED FROM THE HOOP AND REMOVED FROM STENT PROTECTOR DURING PREPARATION, THE DISTAL END OF THE STENT WAS LIFTED AND DAMAGED. BUT THE PROXIMAL PORTION WAS INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13147002 ↗