SYNERGY™ XD H7493941832350Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729981084), received between Jun 9, 2021 and Apr 16, 2026 — classified as 1 death, 7 injuries, 8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE STENT. DURING PREPARATION OF A 3.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT (DES), WHITE THREADS WERE OBSERVED ON THE STENT. A SECOND 3.50 X 32MM SYNERGY XD DES FROM THE SAME LOT ALSO HAD WHITE THREADS. THE PROCEDURE WAS COMPLETED WITH ANTHER STENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897287 ↗
• MalfunctionApr 16, 2026Nonstandard Device; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND ON THE STENT. DURING PREPARATION OF A 3.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT (DES), WHITE THREADS WERE OBSERVED ON THE STENT. A SECOND 3.50 X 32MM SYNERGY XD DES FROM THE SAME LOT ALSO HAD WHITE THREADS. THE PROCEDURE WAS COMPLETED WITH ANTHER STENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24897278 ↗
• InjuryJul 3, 2025Break; Inflation Problem; Nonstandard Device; Difficult to Remove; Material Rupture; Break; Inflation Problem; Nonstandard Device; Difficult to Remove; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE AND SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A 6FR A NON-BOSTON SCIENTIFIC (NON-BSC) INTRODUCER SHEATH WAS INSERTED. AFTER A NON-BSC GUIDEWIRE CROSSED THE LESION, PRE-DILATATION WAS PERFORMED WITH A 3.5X20 MM NC EMERGE BALLOON CATHETER AT 14 ATMOSPHERES. A 3.50 X 32MM SYNERGY XD WAS ADVANCED AND CROSSED THE LESION WITHOUT DIFFICULTY. UPON INFLATION AT 2 ATMOSPHERES, A LACK OF RESISTANCE WAS NOTED IN THE ENCORE ENDEFLATOR. THE TECHNICIAN MADE REPEATED ATTEMPTS WERE MADE TO INFLATE THE STENT BALLOON, BUT THE SAME RESULT WAS OBSERVED. ANGIOGRAPHIC IMAGING CONFIRMED THAT THE STENT BALLOON WAS NOT INFLATING. THE PHYSICIAN ALSO ATTEMPTED INFLATION BUT ENCOUNTERED THE SAME ISSUE, AND IT WAS CONCLUDED THAT THE BALLOON PREMATURELY BURST. DURING WITHDRAWAL, THE DELIVERY SYSTEM BECAME SEPARATED FROM THE STENT AND THE STENT AND BALLOON REMAINED LODGED WITHIN THE LAD, PARTIALLY ENCAPSULATED BY THE GUIDE CATHETER. THE GUIDE CATHETER WAS DEEPLY SEATED IN AN ATTEMPT TO RECAPTURE THE STENT AND DELIVERY SYSTEM. A BALLOON WAS PLACED NEXT TO THE STENT AND DELIVERY BALLOON AND T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22393616 ↗
• MalfunctionJun 12, 2025Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN A TORTUOUS CORONARY ARTERY. A GUIDEZILLA II WAS IN PLACE THROUGH THE GUIDE CATHETER AND SEPARATELY, A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT AND A 3.00 X 24MM SYNERGY XD DRUG-ELUTING STENT WERE ADVANCED FOR TREATMENT, BUT THEY WOULD NOT CROSS THE LESION. UPON ATTEMPT TO REMOVE THE STENTS, THEY BOTH BECAME CAUGHT ON THE GUIDEZILLA HELICAL COLLAR. EACH STENT WAS SIMPLY REMOVED FROM THE PATIENT, BUT WHEN THEY WERE OUT OF THE GUIDE CATHETER, THEY WERE NOT FULLY INTACT OR FULLY CRIMPED ON TO THE BALLOON AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22198743 ↗
• MalfunctionApr 29, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN CORONARY ARTERY. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE SHAFT BROKE IN HALF. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.5X32 SYNERGY XD STENT. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY WITH 85-90% STENOSIS. THE DEVICE WAS COMPLETELY REMOVED BY PULLING IT MANUALLY AND CAME OUT WITH THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926758 ↗
• InjuryMay 31, 2024Break; Nonstandard Device; Difficult to Remove; Break; Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK AND REMOVAL DIFFICULTY OCCURRED WHICH REQUIRED SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). A 3.50 X 32MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR PLACEMENT IN THE RCA. PRE-DILATION WAS NOT PERFORMED. THE STENT WAS DEPLOYED, AND THE BALLOON BECAME STUCK UPON REMOVAL. ADDITIONAL ATTEMPTS TO REMOVE THE BALLOON WERE UNSUCCESSFUL AND RESULTED IN A SHAFT BREAK, LEAVING THE BALLOON PORTION INSIDE THE RCA. AS A RESULT, THE PATIENT WAS SENT TO SURGERY WHERE THEY ATTEMPTED TO REMOVE THE BALLOON, HOWEVER, WERE UNSUCCESSFUL. THE BALLOON WAS LEFT IN THE RCA AND THE PATIENT UNDERWENT A BYPASS TO THE RCA TO TREAT THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Foreign Body In Patient; Reduced Blood Flow

  MAUDE report 19436574 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES), 3.50 X 38MM SYNERGY XD DES, AND A 3.50 X 48MM SYNERGY XD DES WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE THREE DEVICES WERE BROKEN. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949287 ↗
• InjuryMar 19, 2024

  STENT DEPLOYED IN ARTERY, BUT WOULD NOT RELEASE FROM BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 18940735 ↗
• InjuryFeb 2, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE DELIVERY SYSTEM WAS COMPROMISED AND BENT RESULTING TO PARTIALLY DEPLOYED THE STENT. DURING REMOVAL, IT DISLODGED FROM THE SYSTEM LOSING THE STENT IN THE GUIDE AND SHEATH AT THE ACCESS SITE. THE UNDEPLOYED STENT WAS REMOVED, AND THE SECOND STENT WAS PLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18635764 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE PROXIMAL SHAFT BROKE OUTSIDE THE PATIENT AT AROUND 20CM FROM THE HUB. THE DEVICE WAS PULLED OUT AND REPLACED WITH ANOTHER 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT; HOWEVER, THE PROXIMAL SHAFT ALSO BROKE OUTSIDE THE PATIENT AT AROUND 20CM FROM THE HUB. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THE PHYSICIAN BELIEVES THAT HE MAY HAVE EXERTED TOO MUCH FORCE DURING INSERTION CAUSING THE SHAFT TO BREAK AND THAT THE STENTS WERE TANGLED DUE TO HAVING MULTIPLE WIRES IN THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17465945 ↗
• MalfunctionAug 4, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE PROXIMAL SHAFT BROKE OUTSIDE THE PATIENT AT AROUND 20CM FROM THE HUB. THE DEVICE WAS PULLED OUT AND REPLACED WITH ANOTHER 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT; HOWEVER, THE PROXIMAL SHAFT ALSO BROKE OUTSIDE THE PATIENT AT AROUND 20CM FROM THE HUB. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. THE PHYSICIAN BELIEVES THAT HE MAY HAVE EXERTED TOO MUCH FORCE DURING INSERTION CAUSING THE SHAFT TO BREAK AND THAT THE STENTS WERE TANGLED DUE TO HAVING MULTIPLE WIRES IN THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17464440 ↗
• InjuryAug 17, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED RESULTING TO A SURGICAL INTERVENTION. THE TARGET LESION WAS LOCATED IN CIRCUMFLEX VESSEL. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE CATHETER BROKE INSIDE THE VESSEL LEAVING BALLOON AND STENT BEHIND. THE DETACHED PORTION WAS NOT TRIED TO SNARE; RATHER, THE PATIENT WAS SENT TO AN OPEN HEART SURGERY AND THE DETACHED PORTION WAS REMOVED PARTIALLY. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15243221 ↗
• MalfunctionFeb 10, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN INSERTED THE STENT ON THE GUIDEWIRE, IT WAS NOTICED THAT THE STENT WAS NOT EXITING THE GUIDE CATHETER AND WAS GETTING CLOSE TO THE HUB. UPON CHECKING IN THE GUIDE CATHETER, THE DEVICE WAS FRACTURED. THE GUIDE CATHETER, GUIDEWIRE AND STENT WAS REMOVED ALL TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508642 ↗
• DeathDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVOLVE LV XLV STUDY. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE 90% STENOSED TARGET LESION AS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) AND WAS 16MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 4MM. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF 4.00MM X 24MM AND 4.00MM X 28MM STUDY STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. NON TARGET LESIONS WERE ALSO TREATED. THE RAMUS LESION WAS TREATED WITH THE PLACEMENT OF A 2.50MM X 24MM SYNERGY STENT. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2021, A STAGED PROCEDURE WAS PERFORMED. THE NON TARGET LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND MID LAD WERE TREATED USING 3.00MM X 38MM SYNERGY AND 3.50MM X 32MM SYNERGY STENTS IN AN OVERLAPPING FASHION. ON (B)(6) 2021, THE SUBJECT EXPIRED DUE TO UNKNOWN CAUSE OUTSIDE THE HOSPITAL. IN RESPONSE TO THE EVENT, NO ACTION OR DIAGNOSTICS WERE PERFORMED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTED THAT THE PATIENT PASSED AWAY AT HOME. IT WAS FURTHER REPORTED THAT

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087783 ↗
• InjuryOct 5, 2021Difficult to Insert; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Insert; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED CIRCUMFLEX ARTERY AND OBTUSE MARGINAL ARTERY. PREDILATION WAS PERFORMED WITH A 2.5X12MM EMERGE BALLOON CATHETER. A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED IN THE PROXIMAL CIRCUMFLEX ARTERY FOR 14 SECONDS AT 11 ATM. HOWEVER, DURING PROCEDURE, THE STENT DISLODGED AND MIGRATED TO THE AORTA. THE STENT WAS REMOVED VIA SNARE. AN EMERGE 1.5X12MM BALLOON CATHETER WAS INFLATED FOR 29 SECONDS AT 14 ATM IN THE FIRST OBTUSE MARGINAL. SUBSEQUENTLY, A 2.50X28MM A SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WAS DISLODGED. THE STENT WAS REMOVED VIA SNARE. 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 12577011 ↗
• InjuryJun 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% IN-STENT RESTENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS MIDDLE RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATATION, A 3.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED WITHOUT RESISTANCE BEING ENCOUNTERED AND WAS DEPLOYED. DAMAGE WAS THEN NOTED UNDER ANGIO/INTRAVASCULAR ULTRASOUND . THE STENT HAD NOT BEEN POST DILATED. ANOTHER SYNERGY STENT WAS DEPLOYED TO COVER THE DAMAGED PORTION OF THE STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11971152 ↗