SYNERGY™ XD H7493941808270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729980865), received between Dec 5, 2022 and Jan 12, 2026 — classified as 1 death, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• MalfunctionJan 12, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PROXIMAL SHAFT OF THE STENT BROKE WHEN GOING INTO THE WIRE. THE DEVICE WAS REMOVED OFF THE WIRE AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24042611 ↗
• MalfunctionNov 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08NOV2024. A 2.75 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS RETURNED WITH NO REPORTED ALLEGATIONS. HOWEVER, INVESTIGATION RESULT REVEALED A STENT DETACH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798299 ↗
• DeathFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. A 2.75 X 8MM SYNERGY XD DRUG ELUTING-STENT AND LUGE GUIDEWIRE WERE USED DURING PROCEDURE. THE GUIDEWIRE BECAME STUCK ON THE STENT AND THE GUIDEWIRE SHEARED OFF IN THE STENT. ANOTHER STENT WAS PLACED TO TRAP THE GUIDEWIRE IN THE VESSEL WALL. THE PATIENT DIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796502 ↗
• MalfunctionDec 5, 2022Entrapment of Device; Failure to Advance; Device-Device Incompatibility; Entrapment of Device; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE PATIENT PRESENTED WITH ACUTE CORONARY SYNDROME AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED MID OBTUSE MARGINAL ARTERY. AFTER OBTAINING VASCULAR ACCESS VIA THE RIGHT RADIAL ARTERY, A 6F LONG GUIDEZILLA II GUIDE-EXTENSION CATHETER WAS ADVANCED. A 2.75 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED BUT HAD DIFFICULTY ADVANCING IN THE GUIDE-EXTENSION CATHETER. FURTHERMORE, DIFFICULT ANATOMY WAS NOTED AS THE RIGHT SUBCLAVIAN ARTERY AND OBTUSE MARGINAL ARTERY WERE VERY TORTUOUS. SUBSEQUENTLY, THE DEVICE FAILED TO CROSS THE LESION AND GOT STUCK ON THE 014 GUIDEWIRE. THE ENTIRE SYSTEM WAS PULLED OUT AS A UNIT AND THE PROCEDURE WAS COMPLETED WITH PLAIN OLD BALLOON ANGIOPLASTY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15915488 ↗