SYNERGY™ XD H7493941808350Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729981022), received between May 12, 2021 and May 27, 2026 — classified as 1 death, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Fracture; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE PHYSICIAN INITIALLY PERFORMED BALLOON ANGIOPLASTY ON THE LESION AND ATTEMPTED TO DEPLOY A 3.50 X 8MM SYNERGY XD DRUG-ELUTING STENT; HOWEVER, DELIVERY WAS DIFFICULT DUE TO INSUFFICIENT LESION PREPARATION. THE STENT WAS WITHDRAWN WITH THE INTENT TO FURTHER DILATE THE LESION. DURING REMOVAL, THE STENT BECAME LODGED IN THE GUIDE CATHETER, REQUIRING THE PHYSICIAN TO REMOVE THE ENTIRE GUIDE CATHETER FROM THE PATIENT TO RETRIEVE IT. UPON INSPECTION AFTER REMOVAL, ALL COMPONENTS OF THE STENT WERE THERE BUT IT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25308408 ↗
• DeathMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE STENOSED TARGET LESION WAS LOCATED IN THE LEFT MAIN ARTERY. A NON-BOSTON SCIENTIFIC HEART PUMP WAS PLACED, AND AN UNKNOWN SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. THE HEART PUMP WAS REMOVED THE NEXT DAY. THE PATIENT EXPIRED FIVE DAYS LATER; THE PHYSICIAN SUSPECTED STENT CLOTTING OFF AS A POSSIBLE CAUSE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Restenosis

  MAUDE report 18871126 ↗
• MalfunctionFeb 22, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. A 3.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE LOADING THE STENT ONTO A WIGGLE WIRE, APPROXIMATELY 1/4 FROM DISTAL TIP OF DELIVERY DEVICE WAS SEPARATED AND WAS NEVER INTRODUCED INTO THE GUIDE CATHETER. THE BREAK OCCURRED TOWARD DISTAL PORTION APPROXIMATELY AT THE WIRE EXIT PORT. THE PROXIMAL PORTION WAS REMOVED, AND THE DISTAL PORTION WAS PULLED FROM WIRE. ANOTHER SYNERGY STENT WAS USED AND COMPLETED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418426 ↗
• MalfunctionNov 9, 2022Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem; Device Contamination with Chemical or Other Material; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. DURING UNPACKING OF A 3.50 X 8MM SYNERGY XD DRUG-ELUTING STENT, IT WAS NOTED THAT A WHITE PARTICLE WAS PRESENT ON THE TIP OF THE STENT. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15760002 ↗
• MalfunctionNov 15, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT IMPROPER LABELING OCCURRED. A 3.50 X 8MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE SIZE OF THE STENT WITHIN THE BOX WAS INCORRECT. THE BOX WAS LABELED FOR 3.50 X 8MM SYNERGY XD; HOWEVER, THE STENT POUCH WAS 3.5 X 20 XD. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE USED. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811269 ↗
• MalfunctionMay 12, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED TO USE. HOWEVER, DURING INSERTION, THE PHYSICIAN BROKE THE SHAFT OF THE STENT 6 INCHES FROM THE HUB OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11815558 ↗