SYNERGY™ XD H7493941828350Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729981077), received between May 5, 2021 and Dec 3, 2025 — classified as 2 deaths, 4 injuries, 9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2025Nonstandard Device; Difficult to Advance; Nonstandard Device; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-NOV-2025. IT WAS REPORTED THAT DIFFICULTY IN TRACKING OVER WIRE OCCURRED. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT WOULD NOT LOAD ON THE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT POLYMER EXTRUSION RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706211 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REPEAT ANGIOGRAM REVEALED THROMBOSIS OF THE LAD STENT THAT WAS TREATED WITH PTCA AND THROMBECTOMY. THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION REFRACTORY TO AT LEAST 4 ATTEMPTS AT ELECTRICAL DEFIBRILLATION. ADDITIONAL STENT WAS DEPLOYED AND THROMBECTOMY WAS PERFORMED WITH RETURN OF TIMI 3 FLOW. INTRA-AORTIC BALLOON PUMP (IABP) WAS PLACED TO MAXIMIZE CORONARY PERFUSION. IN THE CATH LAB, THE PATIENT RECEIVED 4 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND 5X 25% ALBUMIN. HYPOTENSION REQUIRING IABP INSERTION REQUIRING 4U VASOPRESSORS AND EPINEPHRINE FOR SEVERAL HOURS BEFORE WEANING OFF. IABP REMOVED ON DAY 2 WITH NO COMPLICATIONS. PATIENT WAS EXTUBATED TO HIGH FLOW NASAL CANNULA. INCREASED CARDIAC ENZYMES WERE NOTED POST PROCEDURE.

  Patient problems: Cardiac Enzyme Elevation; Low Blood Pressure/ Hypotension; Obstruction/Occlusion; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 23636639 ↗
• InjuryJun 27, 2025Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT SHAFT BREAK, BALLOON DEFLATION FAILURE, AND REMOVAL DIFFICULTY OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 28 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO THE LESION SITE WITH SOME RESISTANCE NOTED DURING INSERTION AND ADVANCEMENT OF THE DEVICE. DURING BALLOON INFLATION FOR STENT DEPLOYMENT, THE CATHETER SHAFT BROKE IN HALF WITHIN THE PATIENT'S CORONARY ARTERY. THE BALLOON FAILED TO DEFLATE PROMPTLY, RESULTING IN PATIENT PAIN AND DISCOMFORT. THE PHYSICIAN WAS ABLE TO DEFLATE THE BALLOON EVENTUALLY, BUT THE BROKEN CATHETER FRAGMENT COULD NOT BE RETRIEVED WITH A SNARE OR A NON-BOSTON SCIENTIFIC GUIDE CATHETER. THE STENT WAS IMPLANTED, HOWEVER; THE PATIENT WAS REFERRED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY. DURING THE SURGERY, THE RETAINED CATHETER AND BALLOON FRAGMENT WAS SUCCESSFULLY REMOVED. THE PATIENT WAS DISCHARGED AND IS EXPECTED TO MAKE A FULL RECOVERY.

  Patient problems: Discomfort; Pain

  MAUDE report 22351516 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 28MM 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 22171182 ↗
• DeathMay 21, 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 LESIONS WERE LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND LEFT CIRCUMFLEX (LCX) ARTERY. SIX SYNERGY XD DRUG ELUTING STENTS WERE IMPLANTED, A 2.25MM X 12MM, A 2.75MM X 12MM, A 3.00 X 16MM, A 3.00MM X 38MM, A 3.5MM X 28MM AND A 3.5MM X 48MM, WITH NO VISIBLE EDGE DISSECTIONS. TWENTY MINUTES AFTER ARRIVING IN THE RECOVERY UNIT, THE PATIENT COMPLAINED ABOUT CHEST PAIN AND DEVELOPED ST SEGMENT ELEVATION. THE PATIENT WAS BROUGHT BACK TO THE CARDIAC CATHETERIZATION LABORATORY AND THE STENTS IN BOTH THE LAD AND LCX WERE THROMBOSED. THROMBECTOMY WAS PERFORMED IN AN ATTEMPT TO RE-OPEN THE ARTERIES. THE PATIENT CODED FOR SIXTY MINUTES AND EXPIRED.

  Patient problems: Cardiac Arrest; Chest Pain; Non specific EKG/ECG Changes; Thrombosis/Thrombus

  MAUDE report 19368002 ↗
• DeathFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED, AND THE PATIENT DIED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY TO LEFT MAIN. A 2.5 X 32MM, 2.5 X 38MM, 3.5 X 28MM, 3.0 X 12MM SYNERGY XD DRUG ELUTING STENTS AND A 4.0 X 28MM SYNERGY MEGATRON STENT WERE IMPLANTED. THE PATIENT WAS HAVING SYMPTOMS DURING THE WHOLE PROCEDURE, AND THEY GOT EVEN WORSE AFTER THE CASE. IT WAS NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) NUMBERS WERE FINE DURING THE PROCEDURE. HOWEVER, THE ASSUMPTION BY THE PHYSICIAN WAS THAT ONE OR MORE OF THE STENTS THROMBOSED. ANGIOGRAPHY WAS PERFORMED AND ACUTE THROMBOSIS WAS NOTED. ANTIPLATELET WAS GIVEN BEFORE AND DURING THE INITIAL PROCEDURE AND, ALSO, DURING RESCUE. SUBSEQUENTLY, THE PATIENT DIED ON THE SAME DAY AND THERE WAS NO AUTOPSY PERFORMED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18628288 ↗
• MalfunctionSep 4, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE SHAFT WAS BREAK. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675474 ↗
• MalfunctionJun 21, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. THE 75% STENOSED COMPLEX TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 3.50 X 28MM SYNERGY XD STENT WAS ADVANCED FOR TREATMENT AND WAS SUCCESSFULLY IMPLANTED. HOWEVER, WHEN ATTEMPTING TO REMOVE THE STENT DELIVERY SYSTEM, THE SHAFT FRACTURED. IT HAD TO BE REMOVED INSIDE THE GUIDE CATHETER. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE BODY WITHOUT COMPLICATIONS. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17174059 ↗
• MalfunctionJan 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 3.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGING WAS OPENED, IT WAS NOTED THAT THE STENT WAS FRACTURED ON THE BALLOON. THERE WAS NO DAMAGE TO THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272852 ↗
• MalfunctionJan 23, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE STENT DELIVERY SYSTEM BROKE. THE DEVICE WAS REMOVED FROM THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITH A 3.50 X 28MM SYNERGY XD MR DRUG-ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223481 ↗
• InjurySep 15, 2022Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED; THE PATIENT EXPERIENCED VESSEL RUPTURE WITH BLEEDING, RESULTING IN SURGERY. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PATIENT HAD ANGIOGRAMS PERFORMED, AND INTERVENTION WAS ATTEMPTED ON THE LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT, HOWEVER, DURING STENT INFLATION, THE LEFT ANTERIOR DESCENDING ARTERY RUPTURED WITH BLEEDING INTO THE MYOCARDIUM. UPON REMOVAL OF THE SYSTEM IT WAS DISCOVERED THE BALLOON BROKE WITH FRAGMENTS IN THE LAD. AN EMERGENT STERNOTOMY/LIGATION WAS PERFORMED TO REPAIR THE LAD. ULTIMATELY THE PATIENTS LAD WAS NOT ABLE TO RESOLVE AND RAPID, MASSIVE BLOOD INFUSION WAS NEEDED. NO BYPASS WAS PERFORMED AS THE PATIENT HAS LARGE CIRCUMFLEX AND RIGHT CORONARY ARTERY. THE PATIENT WAS THEN TRANSFERRED TO CARDIOVASCULAR INTENSIVE CARE UNIT.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15429367 ↗
• InjuryOct 18, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DEVICE ENTRAPMENT AND SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, THE STENT DELIVERY CATHETER BECAME STUCK IN THE VESSEL. WHEN THE PHYSICIAN ATTEMPTED TO PUSH AND PULL THE DEVICE, THE SHAFT BROKE IN THE AORTA AT APPROXIMATELY 100 CM FROM THE HUB, LEAVING THE DISTAL SHAFT AND STENT ALL INTACT BUT IN THE BODY. THE VESSEL WAS WIRED WITH A SEPARATE WIRE AND DELIVERED A BALLOON DISTAL TO THE BROKEN OFF STENT SHAFT, INFLATED SLIGHTLY AND PULLED EVERYTHING OUT AT ONCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 28MM SYNERGY XD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12648457 ↗
• MalfunctionSep 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. FOLLOWING PRE-DILATATION, A 3.50 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS. UPON REMOVAL OF THE DEVICE, PROXIMAL STENT STRUTS WERE DAMAGED. THE STRUT WAS DAMAGED BUT STAYED INTACT WITH DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.50 X 28MM SYNERGY XD DRUG ELUTING STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457794 ↗
• MalfunctionMay 20, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, CROSSING DIFFICULTIES OCCURRED AND AFTER THE STENT WAS DEPLOYED, THE DELIVERY SYSTEM BALLOON WAS STUCK INSIDE THE STENT. AFTER SEVERAL INFLATIONS AND DEFLATIONS, THE DEVICE WAS FINALLY REMOVED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11860929 ↗
• MalfunctionMay 5, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 3.50 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE SYNERGY XD DRUG-ELUTING STENT COULD NOT BE IMPLANTED. THE SYNERGY XD DRUG-ELUTING STENT DELIVERY SYSTEM WAS REMOVED AND THE SHAFT BROKE INTO TWO PIECES OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH 3.5 X 24MM SYNERGY STENT WITH THE USE OF A GUIDE EXTENSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11779664 ↗