SYNERGY™ XD H7493941812250Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729980797), received between Nov 30, 2021 and Mar 30, 2026 — classified as 1 death, 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Fluid/Blood Leak; Inflation Problem; Nonstandard Device; Activation Failure

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED RESULTING IN STENT DEPLOYMENT ISSUES. THE 90% STENOSED TARGET LESION WAS LOCATED IN A NON-CALCIFIED AND NON-TORTUOUS VESSEL. THE 2.50 X 12 MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. AFTER THE STENT WAS DELIVERED, STENT DELIVERY SYSTEM BALLOON INFLATION WAS ATTEMPTED BUT THE BALLOON COULD NOT HOLD PRESSURE. ONLY PART OF THE STENT WAS DEPLOYED SO IT WAS INFLATED QUICKLY TO FULLY DEPLOY AND COMPLETE THE PROCEDURE. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE BALLOON WAS INFLATED AND WAS FOUND TO HAVE A MAJOR LEAK. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715417 ↗
• MalfunctionJan 30, 2026Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE SHAFT BROKE WHILE TRYING TO INTRODUCE TO THE ARTERY. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220120 ↗
• MalfunctionJan 28, 2026Break; Deformation Due to Compressive Stress; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN INSERTING THE STENT, IT WAS EXPERIENCING DIFFICULTY ADVANCING INTO THE WIRE. THE DELIVERY SHAFT ENDED UP KINKING AND BREAKING COMPLETELY IN THE MID SHAFT. THE STENT WAS STILL IN THE GUIDE, AND THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE SYSTEM WITH NO HARM TO THE PATIENT OR ANY FOREIGN BODY LEFT BEHIND. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24204664 ↗
• InjuryDec 29, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 2.50 X 12MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT PASS THROUGH THE LESION. HOWEVER, DURING THE PROCEDURE WITH REPEATED BALLOON EXCHANGES AND SUBSEQUENT CATHETER REPOSITIONING, A MINOR AORTIC DISSECTION WAS OBSERVED. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: Vascular Dissection

  MAUDE report 23908583 ↗
• MalfunctionJun 30, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DEVICE MOVED ON THE BALLOON. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT IT COULD NOT BE DELIVERED. HOWEVER, IT WAS NOTICED THAT THE STENT WAS LOOSE ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22365863 ↗
• MalfunctionSep 20, 2024Break; Entrapment of Device; Failure to Advance; Break; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT CATHETER ENTRAPMENT AND SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT CORONARY ARTERY. A 2.50 X 12 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE WAS UNABLE TO CROSS THE LESION. FOLLOWING THIS FAILURE, THE STENT WAS RETRACTED BUT BECAME STUCK WITH THE GUIDEWIRE. BOTH THE WIRE AND THE STENT WERE REMOVED TOGETHER OUT FROM THE BODY. ATTEMPTS TO WITHDRAW THE WIRE FROM THE STENT CATHETER WERE UNSUCCESSFUL. AS THE STENT CATHETER WAS WITHDRAWN, THE DISTAL PORTION ABOUT 25-30 CM BACK FROM THE TIP OF THE CATHETER WAS SEPARATED FROM THE MAIN BODY OF THE STENT. THE PROCEDURE WAS COMPLETED USING A COMPLIANT BALLOON. NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271096 ↗
• DeathAug 26, 2024Break; Break

  IT WAS REPORTED THAT THE PATIENT DIED. DURING THE PROCEDURE, A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. UPON DELIVERING THE STENT FOR IMPLANTATION, THE PHYSICIAN ENCOUNTERED RESISTANCE AND THE SHAFT WAS BROKEN. THE DEVICE WAS PULLED MANUALLY AND THE PATIENT WAS BEING TREATED, HOWEVER; THE PATIENT DIED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20070979 ↗
• MalfunctionDec 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT APPEARED TO BE COMING OFF OF THE BALLOON RIGHT OUT OF THE HOOP. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416371 ↗
• InjuryNov 29, 2023Positioning Failure; Failure to Advance; Device Dislodged or Dislocated; Positioning Failure; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT CIRCUMFLEX (LCX) ARTERY. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT WAS STRIPPED OFF OF THE BALLOON PRIOR TO DEPLOYMENT. THE STENT WAS FLOATING IN THE MID LCX AND UNSUCCESSFUL ATTEMPTS WERE MADE TO RECROSS THE STENT WITH A WIRE, SO DEPLOYMENT OF THE STENT WAS NOT POSSIBLE. ALSO, AN UNSUCCESSFUL ATTEMPT WAS MADE TO CRUSH THE STENT AGAINST THE ARTERIAL WALL. THE DEVICE REMAINED INSIDE THE PATIENT AND THE PROCEDURE ENDED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18231684 ↗
• InjuryJul 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, AND MODERATELY TO SEVERELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE STENT CAME OFF THE DELIVERY SYSTEM. ANOTHER GUIDEWIRE WAS ADVANCED INTO THE LAD NEXT TO THE STENT, AND A GUIDEZILLA GUIDE-EXTENSION CATHETER WAS USED TO ATTEMPT TO ENCAPSULATE AND CAPTURE THE STENT, BUT FAILED. SUBSEQUENTLY, A BALLOON CATHETER WAS INSERTED TO CRUSH THE STENT FOLLOWED BY PLACING ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17287346 ↗
• MalfunctionApr 6, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-MAR-2023. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE 75% STENOSED TARGET LESION LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A SMALLER SIZE STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK AT 28CM DISTAL TO THE DISTAL END OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16689125 ↗
• InjuryMar 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE PATIENT WAS PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 70% STENOSED TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ATTEMPTED TO ADVANCE IN DIAGONAL BRANCH. HOWEVER, THE STENT WAS STRIPPED OFF FROM THE STENT DELIVERY SYSTEM. ATTEMPTS WERE MADE TO SLIP A NEW BALLOON INTO THE STENT AND DILATE IT BUT FAILED. FINALLY, THE PHYSICIAN DECIDED TO CRUSH THE STENT INTO THE VESSEL WALL BY BALLOONING AND DEPLOYED ADDITIONAL STENT AND THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16598881 ↗
• MalfunctionDec 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 2.50 X 12MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE STENT FELL OFF THE BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997549 ↗
• MalfunctionJul 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGE OCCURRED. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON LOADING THE STENT INTO THE GUIDEWIRE, THE STENT DETACHED FROM THE DELIVERY 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 15001718 ↗
• MalfunctionJun 1, 2022Positioning Failure; Positioning Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31MAY2022. IT WAS REPORTED THAT DEPLOYMENT FAILURE OCCURRED. THE 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT ADVANCED TO TREAT THE TARGET LESION BUT NO PRESSURE WAS APPLIED AND THE STENT FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A SHAFT FRACTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14565920 ↗
• MalfunctionMar 3, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON WHILE IT WAS BEING DELIVERED TO THE LESION, WHILE IN THE GUIDE CATHETER. THE STENT WAS REMOVED INTACT FROM THE GUIDE CATHETER WITH NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13664871 ↗
• 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 12902359 ↗