SYNERGY™ XD H7493941828500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729981282), received between May 24, 2022 and Aug 13, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2024Break; Material Rupture; Break; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT A CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE. A 5.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING POST-DILATION, THE BALLOON MAINTAINED A POCKET OF FLUID AT THE DISTAL END OF THE STENT BALLOON, AND IT WAS ALSO NOTED THAT THE SHAFT SHEARED AND BROKE INTO TWO PIECES. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978283 ↗
• MalfunctionJun 25, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT WAS BEING TREATED FOR BLOCKAGE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 5.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, RETRACTING THE DEVICE FROM THE CATHETER WAS MORE DIFFICULT THAN USUAL. THE DEVICE WAS PULLED OUT AND NO PHYSICAL DAMAGE WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19606717 ↗
• MalfunctionJun 30, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY-SEVERELY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 5.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AS THE PHYSICIAN WAS DRIVING THE STENT CATHETER UP THE GUIDE, RESISTANCE WAS ENCOUNTERED AND THE PROXIMAL PORTION OF THE SHAFT SNAPPED WHEN REACHING A TORTUOUS PART OF ANATOMY. FURTHERMORE, MULTIPLE ATTEMPTS WERE MADE TO CROSS THE LESION. THE PHYSICIAN WAS ABLE TO PULL AND REMOVE IT OUT FROM THE GUIDE. A NEW SYNERGY XD STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877269 ↗
• MalfunctionMay 24, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS FOUND THAT THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14490969 ↗