SYNERGY™ XD H7493941832400Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 08714729981169), received between Aug 9, 2021 and Feb 20, 2026 — classified as 2 deaths, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 20, 2026Failure to Advance

  IT WAS REPORTED THAT DISSECTION OCCURRED. A 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND A DISSECTION WAS OBSERVED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 24403346 ↗
• MalfunctionFeb 13, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS REPORTED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24333539 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DELIVERY, THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED AND THERE WERE NO COMPLICATIONS REPORTED POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24272623 ↗
• MalfunctionDec 21, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE STENT SHAFT WAS BROKEN. SUBSEQUENTLY, ANOTHER 4.00 X 32MM SYNERGY? XD STENT WAS ADVANCED, AND THE SHAFT WAS ALSO BROKEN. BOTH DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860453 ↗
• MalfunctionDec 21, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE STENT SHAFT WAS BROKEN. SUBSEQUENTLY, ANOTHER 4.00 X 32MM SYNERGY? XD STENT WAS ADVANCED, AND THE SHAFT WAS ALSO BROKEN. BOTH DEVICES WERE PULLED AND REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23860452 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 32MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE SHAFT WAS BROKEN WITHOUT EXCESSIVE FORCE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22171745 ↗
• DeathMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY (RCA). A 1.5MM ROTAPRO BURR WAS SET TO 160K REVOLUTION PER MINUTE (RPM). THE PHYSICIAN WIRED THE RCA WITH A ROTAWIRE DRIVE FLOPPY WIRE. A TEMPORARY PACER WAS SUGGESTED, AND THE PHYSICIAN OPTED FOR AN AMINOPHYLLINE APPROACH. THE PHYSICIAN PASSED THE BURR ONCE IN THE RCA WITH NO DRASTIC DROP IN RPMS. A 3.0X15 NON-BOSTON SCIENTIFIC BALLOON CATHETER WAS THEN USED TO DILATE THE ARTERY. UPON INJECTION AFTER BALLOON UTILIZATION, A TYPE B DISSECTION WAS OBSERVED ALONG WITH NO REFLOW IN THE PROXIMAL TO MIDDLE RCA. A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED, AND THE PATIENT REMAINED STABLE. A MICROCATHETER WAS PLACED DOWN THE VESSEL AND NICARDIPINE WAS ADMINISTERED TO THE PATIENT. A REPERFUSION ARRHYTHMIA APPEARED WITH SIGNIFICANT ST ELEVATION. THE PATIENT SUDDENLY WENT ASYSTOLE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED AND RETURN OF SPONTANEOUS CIRCULATION WAS STARTED. A TEMPORARY PACER AND IMPELLA WERE INSERTED, AND THE PATIENT WAS INTUBATED. HOWEVER, BEFORE LEAVING THE CARDIAC CATHETERIZATION LAB, THE PATIENT DIED. THE OFFICIAL CAUSE OF DEATH WAS CARDIAC ARREST.

  Patient problems: Arrhythmia; Asystole; Cardiac Arrest; Non specific EKG/ECG Changes; Vascular Dissection

  MAUDE report 19285952 ↗
• MalfunctionNov 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD). A US 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS DELIVERED WITH A GUIDEZILLA, HOWEVER, THE STENT SHIFTED ON THE BALLOON. THE STENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18120783 ↗
• DeathSep 28, 2023Break; Break

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED. A SYNERGY XD MR US 4.00 X 32MM WAS SELECTED FOR USE DURING A PERCUTANEOUS CORONARY INTERVENTION. DURING NORMAL ADVANCEMENT, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM HAD BROKEN INTO TWO PIECES. THE PROXIMAL PORTION OF THE DEVICE WAS ABLE TO BE REMOVED AS IT WAS STILL ON THE WIRE. ATTEMPTS WERE MADE TO SNARE THE DISTAL PORTION THAT STILL REMAINED IN THE PATIENT, HOWEVER THESE SNARING ATTEMPTS WERE UNSUCCESSFUL. AFTER THIS, THE PATIENT WAS TAKEN TO THE CARDIOVASCULAR OPERATING ROOM FOR EMERGENCY REMOVAL OF THE FRACTURED DEVICE VIA OPEN HEART SURGERY. DUE TO THIS, THE PATIENT HAD DIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17839393 ↗
• MalfunctionAug 25, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DETACHMENT OCCURRED. THE 70-80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION OF THE DEVICE THE STENT DISLODGED FROM THE BALLOON. THE DEVICE WAS REMOVED , AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17625394 ↗
• InjuryApr 25, 2023Entrapment of Device; Difficult to Remove; Failure to Deflate; Entrapment of Device; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUES OCCURRED. A 12MM X 2.50MM NC QUANTUM APEX AND A 4.00 X 32MM SYNERGY XD WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE STENT WAS SUCCESSFULLY DELIVERED AND EXPANDED, IT WAS NOTED THAT THE BALLOON GOT STUCK IN THE GUIDE. ANOTHER INFLATION DEVICE WAS USED IN AN ATTEMPT TO FULLY DEFLATE THE BALLOON, BUT IT REMAINED STUCK IN THE GUIDE, SO A WIRE WAS USED TO POP AND FURTHER DEFLATE THE BALLOON. NEXT THE NC BALLOON GOT STUCK IN THE GUIDE AFTER DEFLATION AND THE NC BALLOON WAS ALSO POPPED TO FURTHER DEFLATE. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809412 ↗
• MalfunctionJan 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, DURING INSERTION, THE STENT FLARED AT THE END. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED; HOWEVER, DURING INSERTION, THE SHAFT BROKE IN HALF. THE DEVICE WAS REMOVED, AND ANOTHER SYNERGY STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16213786 ↗
• MalfunctionJul 6, 2022Break; Device-Device Incompatibility; Material Deformation; Break; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 32MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED THROUGH A 6FR GUIDEZILLA GUIDE EXTENSION CATHETER FOR TREATMENT. HOWEVER, UPON ADVANCING, RESISTANCE WAS FELT AT THE COLLAR OF THE GUIDEZILLA. AFTER SEVERAL ATTEMPTS ON PUSHING THROUGH THE RESISTANCE, THE PHYSICIAN NOTICED THAT THE STENT DELIVERY SYSTEM (SDS) WAS BENT AND PUSHED ONE MORE TIME AND THE SDS SNAPPED IN HALF DISTAL TO MID FROM THE HUB, CLOSER TO THE MIDDLE SHAFT. THE DEVICE WAS REMOVED BY PULLING OUT FROM THE BODY AND THE PROCEDURE WAS COMPLETED WITH A 4.0X28MM SYNERGY XD DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14936801 ↗
• MalfunctionJun 20, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHILE LOADING ON THE WIRE, OUTSIDE OF THE PATIENT'S BODY, IT WAS NOTICED THAT A STENT STRUT WAS STICKING UP OFF OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14749252 ↗
• MalfunctionJun 6, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NONE TO MILDLY TORTUOUS AND FIBROTIC MID RIGHT CORONARY ARTERY. A 4.00 X 32MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, SLIGHT RESISTANCE WAS MET DURING INTRODUCTION. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE STENT STRUTS APPEARED TO BE LIFTED OR BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605590 ↗
• MalfunctionApr 15, 2022Premature Activation; Material Deformation; Premature Activation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT STENT DAMAGE OCCURRED. A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE STENT WAS PARTIALLY EXPANDED AND WAS SEVERELY FRAYED. THE DEVICE WAS TAKEN OUT OF USE AND EXCHANGED FOR ANOTHER. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14121451 ↗
• MalfunctionApr 4, 2022Material Frayed

  PATIENT WAS BROUGHT TO CARDIAC CATH LAB, PREPPED AND DRAPED IN STERILE FASHION. PROCEDURE WENT AS PLANNED: ANGIOGRAPHY WITH RUNOFF, AND BALLOON ANGIOPLASTY. FINDINGS INCLUDED OCCLUSION OF THE FEMORAL BELOW-KNEE POPLITEAL /TP TRUNK SYNTHETIC GRAFT IN ITS MID SEGMENT, WHICH WAS PREVIOUSLY STENTED, THROMBUS NOTED AT THE DISTAL ANASTOMOSIS TO THE TP TRUNK THAT WAS ALSO PREVIOUSLY STENTED. THE TEAM DECIDED TO PROCEED WITH PERCUTANEOUS INTERVENTION OF THE BYPASS GRAFT AND DISTAL GRAFT-TP TRUNK ANASTOMOSIS. WHEN IT WAS TIME TO USE THE DRUG-ELUTING STENT, THEY FOUND THE STENT PARTIALLY EXPANDED AND SEVERELY FRAYED FROM THE PACKAGE. IT WAS THEN TAKEN OUT OF USE AND EXCHANGED FOR ANOTHER ONE. THE PROCEDURE WENT ON AND WAS COMPLETED WITH NO HARM DONE TO THE PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY¿ XD (PER SITE REPORTER). CATH LAB MANAGER SPOKE TO REPRESENTATIVE AFTER DEVICE WAS TAKEN OUT OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13994270 ↗
• MalfunctionApr 1, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND STENT PARTIAL DEPLOYMENT OCCURRED. DURING UNPACKING OF A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT, IT WAS NOTICED THAT THE STENT STRUTS WERE DAMAGE AND APPEARED TO BE PARTIALLY EXPANDED. 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 13978401 ↗
• MalfunctionAug 9, 2021Fracture; Difficult to Advance; Fracture; Difficult to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION OF A 3.0X12 BALLOON CATHETER, A 4.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT FAILED TO ADVANCE THE LESION. A GUIDE EXTENSION WAS USED TO FACILITATE DELIVERY BUT STILL IT FAILED TO ADVANCE. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE STENT STRUT MIDDLE PART WAS SEPARATED IN TWO PIECES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THAT THE PATIENT STATUS WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12297679 ↗