SYNERGY™ XD H7493941812300Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 08714729980957), received between Dec 14, 2020 and Feb 10, 2026 — classified as 1 death, 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGED OCCURRED. A 3.00 X 12MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND THE STENT CAME OFF THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE DISTAL LEFT MAIN AND CIRCUMFLEX ARTERY. THE STENT SEPARATED FROM THE BALLOON WITHOUT INFLATION, AND ANOTHER BALLOON WAS ADVANCED TO EXPAND THE DISLODGED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306425 ↗
• MalfunctionJan 5, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09DEC2025. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. FOLLOWING PRE-DILATATION WITH 2.5 X 12MM BALLOON CATHETER, A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT CONDITION WAS STABLE POST-PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT STENT WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956995 ↗
• MalfunctionSep 9, 2025Break; Failure to Advance; Material Deformation; Packaging Problem; Break; Failure to Advance; Material Deformation; Packaging Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DEPLOYMENT BUT FAILED TO CROSS THE LESION. UPON INSPECTION, THE PULSIVE PACKAGE SHOWED CORNER DAMAGE, AND THE FOIL PACKAGE SEEMED INTACT. HOWEVER, DURING THE PROCEDURE, THE STENT DELIVERY SHAFT DEVELOPED A KINK, AND A SHAFT BREAK OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23011349 ↗
• MalfunctionSep 4, 2025Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED THAT REMOVAL DIFFICULTY AND STENT MIGRATION OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED AND DEPLOYED. HOWEVER, DIFFICULTY REMOVING THE STENT DELIVERY BALLOON WAS ENCOUNTERED, REQUIRING WITHDRAWAL OF THE GUIDE CATHETER FROM THE DESCENDING AORTA AND THE WIRE. EXCELLENT ANGIOGRAPHIC RESULTS WERE OBSERVED. WEEKS LATER, WHEN THE PATIENT WAS ADMITTED FOR CORONARY ARTERY BYPASS GRAFTING, THE SURGEON MADE AN INCISION AND FOUND A STENT FLOATING FREELY, PRESUMABLY THE SYNERGY XD. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963853 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 12MM 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 22171394 ↗
• MalfunctionJan 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STENT FRACTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A TORTUOUS AND MODERATELY CALCIFIED ARTERY. A 3.00 X 12MM SYNERGY XD MR US AND 6F LONG GUIDEZILLA II WERE SELECTED FOR PERCUTANEOUS CORONARY INTERVENTION. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUTS WERE FRACTURED AS HALF THE STENT REMAINED ON THE BALLOON AND THE OTHER HALF WAS LEFT IN THE GUIDEZILLA. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT ONCE THE STENT STRUT FRACTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21288044 ↗
• MalfunctionSep 18, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION, AND THE STENT DISLODGED. THERE WAS NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20251808 ↗
• MalfunctionAug 23, 2024Fracture; Failure to Advance; Fracture; Failure to Advance

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS FOUND IN THE TORTUOUS AND CALCIFIED MID RIGHT CORONARY ARTERY. A SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR THE TREATMENT. THE DEVICE COULD NOT CROSS THE LESION, AND THE STENT'S EDGES WERE FOUND TO BE DAMAGED UPON REMOVAL. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20057841 ↗
• MalfunctionJun 3, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND VERY CALCIFIED PROXIMAL TO MID OF LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT COULD NOT CROSS DUE TO RESISTANCE AND BECAME STRIPPED OFF THE STENT DELIVERY SYSTEM. THE DEVICE WAS REMOVED FROM INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED WITH A SMALLER STENT, AND THE CASE WAS FINISHED WITHOUT ANY FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19452812 ↗
• MalfunctionMay 24, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT CROSSING DIFFICULTIES AND SHAFT KINK WERE ENCOUNTERED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND A KINK WAS NOTED ON THE MID SHAFT. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED HYPOTUBE LASERCUT REGION DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19397633 ↗
• MalfunctionMay 10, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON-CALCIFIED CORONARY ARTERY. A 3.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PROXIMAL SHAFT BROKE INTO TWO PIECES. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19289340 ↗
• 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 18628290 ↗
• MalfunctionNov 15, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE CRITICAL LESION AND THE DEVICE BROKE INTO THREE PIECES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144518 ↗
• MalfunctionSep 21, 2023Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT IN A MODERATELY TORTUOUS VESSEL. HOWEVER, DURING PROCEDURE, THE DEVICE WAS NOT ABLE TO CROSS THE LESION AND REMOVAL DIFFICULTY WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17792375 ↗
• MalfunctionDec 15, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT WAS BROKEN. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15991975 ↗
• MalfunctionNov 28, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN ATTEMPTED TO PASS THE STENT THROUGH THE GUIDE CATHETER. HOWEVER, DURING INSERTION, THE STENT SHAFT BROKE. THE FRACTURED PORTION WAS LOCATED IN THE PROXIMAL OR MIDDLE OF THE DEVICE. THE STENT WAS PULLED OUT SUCCESSFULLY AND INTACT FROM THE WIRE WITHOUT ANY INTERVENTIONS. A NEW SYNERGY XD 3.00 X 12 WAS USED TO DEPLOY AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874234 ↗
• MalfunctionJun 2, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED VESSEL. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE PROXIMAL SHAFT BROKE WHILE TRYING TO ADVANCE THROUGH THE CALCIFIED LESION. THE DEVICE WAS COMPLETELY REMOVED AND 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 14579042 ↗
• InjuryJun 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WAS DISLODGED WHEN ATTEMPTING TO REPOSITION THE DEVICE. THE STENT WAS REMOVED WITH A SNARE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579018 ↗
• MalfunctionMar 21, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION AND T WAS ALSO NOTED THAT THE STENT WAS DAMAGED. 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 13840904 ↗
• MalfunctionMar 21, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION AND IT WAS ALSO NOTED THAT THE STENT WAS DAMAGED. 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 13840899 ↗
• MalfunctionMar 9, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND STENT DEFORMATION WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13709605 ↗
• InjuryJan 26, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED DIAGONAL BRANCH INTO THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT COULD NOT ADVANCE THROUGH THE LESION. HOWEVER, WHEN THE STENT WAS PULLED BACK, THE STENT CAME OFF THE BALLOON. AFTER NOTICING THE STENT WAS OFF THE BALLOON A SMALL 1.2MM EMERGE BALLOON WAS ADVANCED INTO THE UNDEPLOYED STENT WHICH WAS HALF WAY INTO THE GUIDE. THE EMERGE BALLOON WAS INFLATED SLIGHTLY TO CAPTURE THE STENT INTO THE GUIDE CATHETER. THE WHOLE SYSTEM WAS REMOVED AS ONE UNIT AND EVERYTHING WAS WITHDRAWN. THEN THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359569 ↗
• MalfunctionJul 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN TRIED TO CROSS THE LESION, HOWEVER, THE STENT STRUTS WERE DEFORMED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217073 ↗
• InjuryDec 14, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DISTAL SHAFT SEPARATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE BALLOON WAS INFLATED AT 6 ATMOSPHERES WHEN IT WAS NOTED THAT BLOOD WAS GOING BACK INTO THE INFLATION DEVICE. THE DELIVERY SYSTEM WAS REMOVED FROM THE GUIDE CATHETER, BUT NOTED THAT THE DELIVERY BALLOON HAD DISCONNECTED FROM THE SHAFT AND REMAINED INSIDE THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE TO DELIVER SEVERAL EMERGE BALLOON CATHETERS TO CRUSH THE STENT AND BALLOON. A 3.50 X 16MM SYNERGY XD STENT WAS PLACED TO JAIL THE INITIAL STENT AND BALLOON AGAINST THE VESSEL WALL. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 11004198 ↗