SYNERGY™ H7493926020500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729973447), received between May 21, 2019 and Dec 9, 2024 — classified as 4 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.

• MalfunctionDec 9, 2024Migration; Failure to Deflate; Migration; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUES OCCURRED. UPON DEPLOYMENT OF A 5.0 X 20 SYNERGY DRUG-ELUTING STENT AT THE PROXIMAL SEGMENT OF THE RIGHT RENAL ARTERY, IT WAS OBSERVED THAT THE STENT BALLOON DID NOT FULLY DEFLATE, ONLY THE PROXIMAL PART DEFLATED. THE DELIVERY SYSTEM WAS REMOVED BUT THIS PARTIAL DEFLATION RESULTED IN A SEGMENT OF THE STENT BEING INADVERTENTLY PULLED INTO THE AORTA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20880858 ↗
• MalfunctionDec 3, 2020Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT A SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED ARTERY. A 5.00 X 20 SYNERGY II DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE GOT STUCK AND FRACTURED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10938127 ↗
• MalfunctionNov 18, 2019Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. A 5.00X20MM SYNERGY II DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM WOULD NOT DRAW BACK INTO THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT AFTER THE CATHETER WAS STUCK POST STENT DEPLOYMENT, THE DEVICE WAS PULLED NEGATIVE TWICE ON THE INFLATION DEVICE AND IT WAS ABLE TO RETURN BACK INTO THE GUIDE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9335673 ↗
• MalfunctionMay 21, 2019Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT STENT BECAME DAMAGED DURING WITHDRAWAL THROUGH THE GUIDE EXTENSION CATHETER. A 6FR GUIDEZILLA II AND A 5X20 SYNERGY STENT WERE SELECTED FOR USE FOR A CORONARY INTERVENTION PROCEDURE IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, A LOT OF RESISTANCE WAS FELT ADVANCING THE STENT THROUGH THE GUIDEZILLA. THE PHYSICIAN ATTEMPTED TO PULL THE STENT OUT OF THE GUIDEZILLA, BUT THE STENT STRUTS BECAME DAMAGED. THE STENT REMAINED ON THE DELIVERY BALLOON, HOWEVER, THE BALLOON WAS STICK IN THE GUIDEZILLA. THE PHYSICIAN THEN REMOVED EVERYTHING FROM THE PATIENT. THE PHYSICIAN THOUGHT THAT THE 5X20 SYNERGY WAS TOO LARGE TO FIT THROUGH THE GUIDEZILLA. THE PROCEDURE WAS COMPLETED BY USING A NEW GUIDEZILLA AND A SMALLER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8627473 ↗