SYNERGY™ H7493926116250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729840572), received between Feb 19, 2020 and Mar 30, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• InjuryMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND HEAVILY CALCIFIED CIRCUMFLEX ARTERY. A 2.50 X 16 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS LOCATED IN THE VESSEL AND WAS SUBSEQUENTLY CRUSHED AND SECURED BY A NEW STENT. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED. THE PATIENT WAS DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 9898103 ↗
• InjuryFeb 19, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED. THE PATIENT PRESENTED WITH ST-ELEVATION MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.50X16MM SYNERGY DRUG-ELUTING STENT WAS THEN DEPLOYED. THE PATIENT WAS SENT TO INTENSIVE CARE UNIT AND 45 MINUTES LATER, STENT THROMBOSIS WAS NOTED. ANOTHER BSC STENT WAS IMPLANTED FOR TREATMENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: Thrombosis

  MAUDE report 9729439 ↗