SYNERGY™ XD H7493941824500Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729981275), received between Mar 12, 2021 and Feb 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT MAIN CORONARY ARTERY. A 5.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE BALLOON WAS INFLATED TO APPROXIMATELY 12 ATM AND THE STENT WAS IMPLANTED WITHOUT DIFFICULTY. DURING REMOVAL AND AFTER BALLOON DEFLATION, RESISTANCE WAS NOTICED WHEN REMOVING, AND THE BALLOON BECAME LODGED WITHIN THE STENT. AT THE SECOND ATTEMPT, THE STENT BALLOON WAS SUCCESSFULLY PULLED INTO THE GUIDE CATHETER, BUT THE STENT DELIVERY SHAFT FRACTURED AND BROKE APART NEAR THE MONORAIL WIRE EXIT PORT WITHIN THE GUIDE CATHETER. THE DETACHED PORTION OF THE DEVICE WAS REMOVED INSIDE THE GUIDE CATHETER FROM THE PATIENT. IT WAS NOTED THAT VACUUM WAS APPLIED AND HELD DURING BALLOON WITHDRAWAL. PHYSICAL DAMAGE WAS OBSERVED POST-PROCEDURE, AND THE BALLOON WAS DEFLATED PRIOR TO REMOVAL. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18773358 ↗
• InjuryOct 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 5.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE, THE STENT DETACHED FROM THE BALLOON INSIDE THE PATIENT. THE DEVICE WAS REMOVED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958069 ↗
• MalfunctionMar 12, 2021Difficult to Remove; Failure to Advance; Defective Device; Difficult to Advance; Difficult to Remove; Failure to Advance; Defective Device; Difficult to Advance

  IT WAS REPORTED THAT DIFFICULTY REMOVAL WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 5.00 X 24MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. THE SYNERGY XD DRUG ELUTING STENT WAS ADVANCED BUT COULD NOT CROSS THE LESION. UPON REMOVAL THE SYNERGY XD DRUG ELUTING STENT, THE STENT WAS CATCHING ON THE CATHETER. IT WAS OBSERVED THAT THE BALLOON WAS SLIGHTLY INFLATED ON EACH END OF THE STENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474135 ↗