SYNERGY™ XD H7493941808400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729981107), received between Nov 3, 2021 and May 27, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 8MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED AND INSERTED OVER THE WIRE INTO A NON-BOSTON SCIENTIFIC GUIDE. HOWEVER, THE SHAFT WAS BROKEN FOR ABOUT 18 INCHES FROM THE HUB. THE DEVICE WAS PULLED OUT TOGETHER WITH THE WHOLE SYSTEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087097 ↗
• MalfunctionFeb 1, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT SHAFT HOLE AND BREAK OCCURRED. A 4.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING ATTEMPTED LOADING, THE GUIDEWIRE EXITED THE SHAFT AND THE BALLOON, AND THE DEVICE FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625807 ↗
• InjuryAug 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 90% STENOSED, TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. UPON REPOSITIONING, THE STENT WAS DISLODGED. THE STENT WAS CRUSHED TO THE SIDE WALL OF THE VESSEL AND THE PROCEDURE COMPLETED SUCCESSFULLY WITH A 3.75X12 NC EMERGE BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229486 ↗
• MalfunctionNov 3, 2021Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT FAILURE TO ADVANCE OCCURRED. A 4.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, FAILED TO CROSS THE LESION AND ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI) OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. IT WAS FURTHER REPORTED THAT THE NO CROSS EVENT DID NOT CAUSE THE STEMI.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Non specific EKG/ECG Changes

  MAUDE report 12745340 ↗