SYNERGY™ H7493926012450Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729973348), received between Nov 27, 2019 and Dec 10, 2020 — classified as 2 malfunctions.

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

• MalfunctionDec 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 4.50 X 12 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT STRUT WERE FRACTURED AND BROKE INTO TWO PIECES. THE PROCEDURE WAS COMPLETED WITH A SECOND STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10987166 ↗
• MalfunctionNov 27, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.50 X 12 SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS. WHEN THE DEVICE WAS REMOVED FOR ADDITIONAL VESSEL PREPARATION, IT WAS NOTED THAT SOME OF THE STENT STRUTS HAD PULLED AWAY FROM THE STENT DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9387827 ↗