SYNERGY™ XD H7493941812500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729981244), received between Feb 9, 2022 and Dec 26, 2025 — classified as 2 injuries, 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Nonstandard Device; Premature Activation; Nonstandard Device; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 5.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS PARTIALLY DEPLOYED AND PHYSICIAN DECIDED NOT TO USE IT. THEY PULLED ANOTHER DEVICE AND WORKED PERFECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899024 ↗
• MalfunctionMar 25, 2025Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Failure to Deflate; Difficult to Remove; Failure to Advance; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED THAT BALLOON ISSUES OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED LEFT MAIN. A 5.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED BUT WAS UNABLE TO CROSS THE LESION. AFTERWARDS, DILATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC (NON-BSC) SCORING BALLOON AND THE STENT WAS THEN ABLE TO CROSS THE LESION. FOLLOWING STENT DEPLOYMENT, THE DELIVERY SYSTEM BALLOON WAS DIFFICULT TO DEFLATE SO THE DOCTOR DID TWO EXTRA NEGATIVE PULLS ON THE INFLATION DEVICE. WHEN THE DOCTOR ATTEMPTED TO WITHDRAW THE BALLOON, IT WOULD NOT RETRACT INTO THE GUIDE CATHETER. WHEN THE STENT DELIVERY SYSTEM CATHETER WAS FINALLY ABLE TO BE REMOVED, IT WAS NOTED THAT THE BALLOON HAD DETACHED AND WAS STILL ON THE NON-BSC GUIDEWIRE, IN THE LEFT MAIN CORONARY ARTERY. THE GUIDEWIRE AND BALLOON WERE ABLE TO BE SNARED FOR REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690600 ↗
• MalfunctionJul 25, 2023Break; Material Deformation; Failure to Deflate; Break; Material Deformation; Failure to Deflate

  IT WAS REPORTED THAT A SHAFT BREAK AND BALLOON DEFLATION ISSUES OCCURRED. THE PATIENT UNDERWENT RENAL ARTERY STENTING. A 5.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND WAS DEPLOYED AT 12 ATMOSPHERES FOR 30 SECONDS. HOWEVER, THE SHAFT WAS KINKED SLIGHTLY UPON INSERTION. POST STENT IMPLANTATION, THE BALLOON FAILED TO DEFLATE. WHEN THE DEVICE WAS REMOVED, THE SHAFT BROKE OFF. THE DEVICE WAS TRAPPED INSIDE OF THE GUIDE CATHETER AND THE ENTIRE SYSTEM WAS REMOVED FULLY DEFLATED. THE PROCEDURE WAS COMPLETED, WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390705 ↗
• MalfunctionJan 18, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS OPENED; HOWEVER, WHEN REMOVED FROM THE PLASTIC COVER, THE SHAFT WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196259 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY: IT WAS REPORTED THAT OCCLUSION OCCURRED. IN (B)(6) 2021, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN SAPHENOUS VEIN GRAFT (SVG) TO LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 MM X 20 MM SYNERGY MEGATRON STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW 3. A NON TARGET LESION IN THE SVG WAS TREATED WITH PLACEMENT OF A 5.00 MM X 12 MM SYNERGY STENT. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT WAS NOTED TO HAVE SYMPTOMS RELATING TO CORONARY ARTERY DISEASE. A WEEK LATER THE SUBJECT VISITED THE HOSPITAL WITH COMPLAINTS OF CONTINUED SYMPTOMS OF CHEST TIGHTNESS AND SHORTNESS OF BREATH WITH MINOR ACTIVITY DESPITE BEING ON A MULTIPLE ANTI-ANGINAL MEDICATION REGIMEN. CARDIAC CATHETERIZATION WAS PERFORMED WHICH REVEALED AN OCCLUDED SVG TO RAMUS AND OBTUSE MARGINAL, WITH TIMI FLOW OF 1. THE SUBJECT WAS ADVISED FOR MEDICAL TREATMENT VERSUS REDO OF BYPASS GRAFT OR PERCUTANEOUS CORONARY INTERVEN

  Patient problems: Angina; Chest Pain; Dyspnea; Obstruction/Occlusion

  MAUDE report 15621046 ↗
• InjuryFeb 9, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AFTER A 5.00X12MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED, THE STENT DELIVERY SYSTEM (SDS) BALLOON WOULD NOT COME THROUGH THE DISTAL END OF THE GUIDE CATHETER EVEN AFTER MULTIPLE ATTEMPTS. WHEN THE DEVICE WAS PULLED HARDER, THE SHAFT BROKE AT THE DISTAL END NEAR THE BALLOON. THE PHYSICIAN USED A GUIDEZILLA TO ENGULF THE BALLOON SUCCESSFULLY. THE GUIDEZILLA, SDS, AND GUIDE WERE THEN REMOVED SIMULTANEOUSLY. THE SDS BALLOON WAS REMOVED FULLY DEFLATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500624 ↗