SYNERGY™ XD H7493941832250Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729980841), received between Nov 2, 2020 and Oct 29, 2025 — classified as 2 deaths, 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• InjuryOct 29, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED RESULTING IN PATIENT IMPACT. A 2.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED IN AN ATTEMPT TO TREAT THE LESION; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. SUBSEQUENTLY, THE PATIENT WAS OBSERVED TO HAVE BECOME HYPOTENSIVE. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE EVENT.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 23417510 ↗
• MalfunctionFeb 19, 2025Failure to Advance; Failure to Deflate; Failure to Advance; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. 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 SEVERELY CALCIFIED VESSEL. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, THE STENT HAD DIFFICULTY TO TRACK THE LESION AND DEFLATION ISSUE WAS ALSO NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417348 ↗
• InjuryNov 27, 2024Break; Failure to Advance; Device-Device Incompatibility; Break; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH DISEASE THROUGHOUT THE WHOLE VESSEL VIA ANGIOGRAPHY AND WAS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE FIRST STENT PLACEMENT WAS SUCCESSFUL WITH THE USE OF A NON-BOSTON SCIENTIFIC (BSC) GUIDE EXTENSION CATHETER TO AID IN DELIVERABILITY AND SUPPORT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO ADVANCE THE SECOND STENT IN BETWEEN A NON-BOSTON SCIENTIFIC (BSC) GUIDE EXTENSION CATHETER AND THE FIRST STENT, THE STENT GOT CAUGHT ON THE PROXIMAL EDGE OF THE FIRST STENT AND POSSIBLY ON CALCIUM AND RESISTANCE WAS ENCOUNTERED. CONSEQUENTLY, THE BALLOON CATHETER BROKE OFF DUE TO THE RESISTANCE INSIDE THE VESSEL, LEAVING THE BALLOON AND STENT SEPARATED FROM THE DELIVERY SYSTEM. THE PHYSICIAN WAS ABLE TO RETRIEVE THE STENT AND THE DISTAL BALLOON CATHETER WITH A SNARE. A NEW STENT WAS PLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20800862 ↗
• InjuryNov 8, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK AND DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). FOLLOWING SUCCESSFUL ATHERECTOMY AND PRE-DILATATION, A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. THE DEVICE WAS DIFFICULT TO DELIVER TO THE LESION THROUGH A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER DUE TO TORTUOSITY. UPON INFLATION AND DEPLOYMENT, THE INFLATION DEVICE LOST PRESSURE, AND IT WAS DISCOVERED THAT THE STENT SHAFT SNAPPED. AFTER SEVERAL FAILED ATTEMPTS TO SNARE THE DEVICE FRAGMENTS, THE BROKEN DISTAL SHAFT, BALLOON, AND STENT HAD TO BE SECURED UP AGAINST THE RCA WITH AN ADDITIONAL STENT. THE PROXIMAL PORTION OF THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20643681 ↗
• MalfunctionSep 26, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT; HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED FROM THE BALLOON AND FAILED TO CROSS THE LESION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20314916 ↗
• DeathMay 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND PATIENT DEATH OCCURRED. THE PATIENT PRESENTED WITH ST ELEVATION MYOCARDIAL INFARCTION AND CORONARY ARTERY DISEASE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT GROIN. IMAGING SHOWED SEVERELY CALCIFIED CORONARY ARTERIES AND THE 80-90% STENOSED MID LAD WAS IDENTIFIED AS THE CULPRIT VESSEL. A PREVIOUS STENT WAS PRESENT IN THE PROXIMAL LAD. PRE-DILATION OF THE MID LAD WAS PERFORMED USING A 2.50 X 12 MM NC EMERGE BALLOON. A 2.50 X 32 MM SYNERGY XD STENT WAS ADVANCED TO THE MID LAD BUT BECAUSE THE STENT WAS TOO LONG, IT WAS REMOVED UNDEPLOYED. WHEN ANOTHER PICTURE WAS TAKEN WITH CONTRAST HOWEVER, IT WAS APPARENT THE UNDEPLOYED STENT WAS STILL IN THE PROXIMAL LAD. THE PHYSICIAN THOUGHT THE STENT CAUGHT ON CALCIUM IN THE VESSEL AND CAME OFF THE DELIVERY SYSTEM DURING RETRIEVAL. REWIRING OF THE LAD TO ATTEMPT TO CRUSH THE DISLODGED STENT WAS UNSUCCESSFUL AND AN ATTEMPT TO IMPLANT A LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS ALSO UNSUCCESSFUL DUE TO THE HEAVILY CALCIFIED VESSELS; SEVERAL STENTS WERE PRESENT IN THE ILIAC VESSEL MAKING IT EXTREMELY DIFFICULT TO ADVANCE THE LVAD THROUGH THE LEFT GROIN. DURING

  Patient problems: Foreign Body In Patient; Ventricular Fibrillation

  MAUDE report 19235060 ↗
• 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 18628344 ↗
• InjuryApr 11, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY TO POSTERIOR DESCENDING ARTERY. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING WITHDRAWAL, THE DISTAL CATHETER SHAFT BROKE OFF IN THE PATIENT. PHYSICIAN TRIED TO SNARE THE BROKEN PIECE FROM THE PATIENT, BUT IT WAS UNSUCCESSFUL. PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND WAS SENT FOR CORONARY ARTERY BYPASS GRAFT (CABG) TO RETRIEVE THE DETACHED DEVICE FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714015 ↗
• MalfunctionMar 30, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM BROKE DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16642621 ↗
• InjuryFeb 7, 2023Break; Difficult to Remove; Difficult to Advance; Activation Failure; Break; Difficult to Remove; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT SHAFT BREAK, INSUFFICIENT STENT APPOSITION, AND DEVICE EXPLANTATION OCCURRED. THE 90% IN-STENT RESTENOSIS TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING. THERE WAS DIFFICULTY WITH MAINTAINING ACCESS DURING PROCEDURE AND HAD DIFFICULTIES DELIVERING UNKNOWN BOSTON SCIENTIFIC BALLOON CATHETERS. A GUIDEZILLA EXTENSION CATHETER WAS USED TO HELP FACILITATE DELIVERY AND MAINTAIN ACCESS WITH GUIDING CATHETER. AFTER MULTIPLE ATTEMPTS AT PRE DILATING THE PHYSICIAN DECIDED TO STENT. A 2.50 X 32MM SYNERGY XD STENT WAS ADVANCED FOR TREATMENT AFTER SOME STRUGGLE TO GET THE STENT WHERE IT WAS NEEDED. THE PHYSICIAN INFLATED THE BALLOON OF THE STENT DELIVERY SYSTEM (SDS) AT 18 ATMOSPHERES. HOWEVER, THERE WAS AN AREA IN THE DISTAL PORTION OF THE STENT THAT LOOKED TO BE UNDER DEPLOYED. AFTER DEFLATING THE SDS, THE PHYSICIAN TRIED TO REMOVE THE SDS BUT HAD RESISTANCE. MULTIPLE ATTEMPTS WERE MADE AT REMOVING THE SDS WHICH RESULTED IN THE FRACTURING AND DISLODGMENT OF THE POLYMER PORTION OF THE SDS. THE HYPOTUBE PORTION OF THE SDS WAS REMOVED FROM THE GUIDE AND THE BALLOON PORTION OF THE SDS REMAINED IN THE PATIENT'S CORONARY ARTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315824 ↗
• MalfunctionJan 27, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT MOVED ON BALLOON OCCURRED. A 2.50 X 32MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS PARTIALLY DETACHED FROM THE BALLOON. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13366691 ↗
• MalfunctionNov 29, 2021Break; 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 THE MODERATELY TORTUOUS AND MILDLY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING ROTATIONAL ATHERECTOMY WAS PERFORMED, A 2.50 X 32MM SYNERGY XD STENT WAS ADVANCED FOR DILATATION. HOWEVER, DURING ADVANCING, THE SHAFT BROKE 15-20 CENTIMETERS DISTAL FROM THE HUB. THE DEVICE WAS SIMPLY PULLED OUT OF THE GUIDE CATHETER INTACT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12882161 ↗
• MalfunctionJun 21, 2021Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO BE DELIVERED. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE PROXIMAL END OF THE STENT WAS DEFORMED. ANOTHER 2.50 X 38MM SYNERGY XD DES WAS ADVANCED; HOWEVER, THE DEVICE ALSO FAILED TO BE DELIVERED AND UPON REMOVAL, IT WAS DETERMINED THAT THE PROXIMAL END OF STENT GOT DEFORMED. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12038098 ↗
• MalfunctionApr 8, 2021Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-MAR-2021. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. A 2.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT, BUT FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633797 ↗
• MalfunctionNov 2, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THIS 2.50 X 32MM SYNERGY XD WAS USED FOR A PERCUTANEOUS CORONARY INTERVENTION IN THE RIGHT CORONARY ARTERY. THE BALLOON RUPTURED AFTER DEPLOYING THE STENT. NO PATIENT COMPLICATIONS OCCURRED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS INFLATED TO 11 ATMOSPHERES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10771805 ↗