SYNERGY™ XD H7493941828270Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729980919), received between Sep 20, 2021 and Feb 4, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionFeb 4, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED VESSEL. A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED WITHOUT ANY ISSUES. HOWEVER, WHEN PULLING THE STENT BALLOON OUT OF THE PATIENT'S BODY OVER A NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE, IT WAS NOTED THAT THE MONORAIL PORTION SEPARATED FROM THE STENT SHAFT AT THE POINT WHERE THE MONORAIL PORTION WAS FUSED. THE MONORAIL PORTION REMAINED ON THE WIRE INSIDE THE GUIDE, AND EVERYTHING WAS PULLED OUT IN ONE PIECE; AND NOTHING WAS LEFT INSIDE THE PATIENT'S BODY. IN ADDITION, THERE WERE NO NOTICEABLE DAMAGE OBSERVED ON THE SHAFT OF THE STENT DELIVERY DEVICE PRIOR TO DEPLOYMENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259078 ↗
• MalfunctionJan 21, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE >70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED IN OBTUSE MARGINAL ARTERY. FOLLOWING PRE-DILATION, A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WOULD NOT CROSS THE LESION. THE PHYSICIAN PULLED THE STENT BACK OUT AND IT WAS NOTICED THAT THE STENT WAS DAMAGED AND LOOKED LIKE IT GOT CAUGHT ON SOMETHING AND "UNRAVELED." THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13318334 ↗
• InjuryOct 7, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED, HOWEVER, THE STENT DELIVERY SYSTEM BECAME STUCK INSIDE OF THE STENT. A SECOND WIRE WAS USED TO SUCCESSFULLY REMOVE THE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594541 ↗
• MalfunctionSep 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED CORONARY ARTERY. A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION, IT WAS NOTED THAT THE STENT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12502204 ↗