SYNERGY™ XD H7493941838220Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729980773), received between Dec 23, 2020 and Jul 29, 2026 — classified as 1 death, 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient complications occurred. The patient was on GPIIb/IIIa inhibitors and on prior regimen of Aspirin (>= 72 hours) and antiplatelet other than Aspirin (>= 72 hours) at the time of the procedure. A loading dose of 300mg of clopidogrel was given prior to the procedure. The 40 mm x 2.00 mm target lesion was located in the first obtuse marginal branch of the left circumflex artery (LCx) and was pre-treated with a 2.00 mm x 30 mm semi-compliant balloon angioplasty catheter resulting in 0% residual stenosis and TIMI flow 3. The target lesion was then successfully treated with a 2.25 mm x 38 mm Synergy XD drug eluting stent resulting in 0% residual stenosis and TIMI flow of 3. A non-target lesion extending from the distal left anterior descending artery (LAD) to the mid LAD was successfully treated prior to the treatment of target lesion using a 2.25 mm x 38 mm drug eluting stent and a 2.50 mm x 16 mm drug eluting stent. Post-procedure, elevated cardiac enzymes were detected and the patient was diagnosed with myocardial infarction. The patient was discharged from the hospital with the continuation of aspirin and clopidogrel medications.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50073594 ↗
• MalfunctionMay 5, 2026Activation Failure

  IT WAS REPORTED STENT MALPOSITION OCCURRED. IN (B)(6) 2026, THE PATIENT WAS ON A PRIOR REGIMEN OF ANTIPLATELET MEDICATION OTHER THAN ASPIRIN (GREAT THAN OR EQUAL TO 72 HOURS). THE 2.25 MM X 25 MM TARGET LESION WAS LOCATED AT THE FIRST DIAGONAL ARTERY. THE TARGET LESION WAS PRE-TREATED WITH A 2.25 MM X 12 MM WOLVERINE AND A NON-COMPLIANT BALLOON RESULTING IN 30% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE 2.25 MM X 38 MM SYNERGY XD STENT SUCCESSFULLY TREATED THE TARGET LESION RESULTING IN 0% RESIDUAL STENOSIS AND TIMI FLOW 3. ON THE SAME DAY OF THE PROCEDURE, IVUS CONCLUDED THE PRE-TREATMENT WITH THE WOLVERINE DEVICE DEMONSTRATED THE PRESENCE OF MEDIAL DISSECTION. IVUS ALSO NOTED STENT MALPOSITION WITH THE SYNERGY XD STENT. THE PATIENT DISCHARGED FROM HOSPITAL. ON ASPIRIN AND CLOPIDOGREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25082282 ↗
• DeathMar 30, 2026Failure to Advance; Material Deformation

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS MID-LEFT CIRCUMFLEX ARTERY (LCX). THERE WAS SOFT PLAQUE BUT NO SIGNIFICANT CALCIFICATION. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION, REQUIRING REMOVAL. A SECOND ATTEMPT WAS MADE, BUT THE DEVICE AGAIN COULD NOT CROSS AND WAS REMOVED. HOWEVER, UPON WITHDRAWAL, THE STENT WAS FOUND TO BE DEFORMED, WITH A SEGMENT OF METALLIC MESH PROTRUDING BEYOND THE CONTOUR OF THE STENT STRUTS. IMMEDIATELY AFTER REMOVAL OF THE DEFORMED STENT, REPEAT ANGIOGRAPHY DEMONSTRATED A SPIRAL DISSECTION IN THE MID-LCX, ATTRIBUTED TO THE STENT DEFORMATION. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS ADVANCED THROUGH THE DISSECTION FLAP TO REGAIN ACCESS AND FACILITATE VESSEL REPAIR. THE WIRE CAUSED A SMALL PERFORATION DISTAL TO THE FLAP, AND ECHOCARDIOGRAPHY REVEALED A SMALL EFFUSION. A 2.25 X 20 MM DES WAS SUCCESSFULLY DEPLOYED, AND THE PROCEDURE WAS COMPLETED USING A COMPLEX DISSECTION REPAIR TECHNIQUE. NO FURTHER ISSUES WERE REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED FROM CARDIAC TAMPONADE.

  Patient problems: Cardiac Tamponade; Vascular Dissection

  MAUDE report 24735240 ↗
• MalfunctionFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING UNPACKING, THE STENT HAD SEPARATED FROM THE BALLOON, AND THE STENT PROTECTOR HAD BEEN REMOVED FIRST. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413294 ↗
• MalfunctionDec 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING PREPARATION OF A 2.25 X 38MM SYNERGY? XD DRUG-ELUTING STENT, IT WAS NOTED THAT THE STENT HAD COMPLETELY DETACHED FROM THE BALLOON. THE DEVICE NEVER INTRODUCED INTO THE PATIENT, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926921 ↗
• InjurySep 2, 2025Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation; Difficult to Remove; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE BALLOON WAS INFLATED AT NOMINAL PRESSURE FOR 30 SECONDS TO IMPLANT THE STENT. THE BALLOON WAS THEN FULLY DEFLATED FOR 10 SECONDS. HOWEVER, THE BALLOON BECAME STUCK AND FAILED TO RETRACT. THE DEVICE WAS EVENTUALLY REMOVED USING A GUIDE EXTENSION CATHETER, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS NOTED THAT THE CATHETER HYPOTUBE WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936220 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. AN OPTICROSS IMAGING CATHETER WAS USED BUT BECAME KINKED INSIDE THE PATIENT DURING DELIVERY POST-STENT PLACEMENT, RESULTING IN A LOSS OF IMAGING. THE DEVICE WAS REMOVED, AND A 2.25 X 38 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, THE STENT BROKE AT THE PROXIMAL STAINLESS-STEEL SHAFT AND SNAPPED INSIDE THE PATIENT. THE DEVICE WAS REMOVED, AND ANOTHER 3.50 X 24 MM SYNERGY XD DES WAS THEN SELECTED, BUT IT ALSO BROKE AT THE PROXIMAL STAINLESS-STEEL SHAFT AND SNAPPED INSIDE THE PATIENT. THE DEVICE WAS ALSO REMOVED BY JUST PULLING THEM BACK OUT OVER THE WIRE. THE HUB OF BOTH STENTS WAS DETACHED OUTSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688769 ↗
• MalfunctionJun 7, 2024Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS SEVERELY TORTUOUS AND MODERATELY CALCIFIED. FOLLOWING PRE-DILATION, A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING PROCEDURE, THE PHYSICIAN TRIED TO CROSS THE STENT THROUGH A 6F TELESCOPE NON-BOSTON SCIENTIFIC GUIDE EXTENSION BUT FAILED DUE TO THE STENT WAS STUCK IN THE ARTERY. WHEN TRYING TO REMOVE THE STENT AND GUIDE EXTENSION, THE STENT GOT DAMAGED. THE PHYSICIAN THEN DECIDED TO REMOVE ALL THE EQUIPMENT AND START OVER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19489175 ↗
• InjuryJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 38 SYNERGY XD DRUG ELUTING STENT WAS ADVANCED WITHOUT RESISTANCE USING A 0.014-INCH GUIDEWIRE AND 6F GUIDE CATHETER. NO INTERACTIONS WITH OTHER DEVICES WERE NOTED. HOWEVER, THE STENT DISLODGED WITHIN THE RADIAL SHEATH AND WAS SUCCESSFULLY RETRIEVED USING A SNARE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19449164 ↗
• MalfunctionNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 2.25 X 38 MM SYNERGY STENT FELL OFF OF THE BALLOON BEFORE BEING INSERTED INTO THE BODY. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145511 ↗
• MalfunctionOct 29, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT SHAFT HOLE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 38MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT BALLOON WOULD NOT INFLATE. IT WAS FOUND THAT CONTRAST WAS LEAKING OUT OF THE STENT DELIVERY CATHETER. THE DEVICE WAS PULLED OUT AND SHAFT PINHOLE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18027079 ↗
• MalfunctionMay 16, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE DEVICE BROKE WHILE BEING LOADED ONTO AN INTERVENTIONAL WIRE. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16942922 ↗
• MalfunctionNov 30, 2022Packaging Problem; Packaging Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT PACKAGING DAMAGE OCCURRED. A 2.25 X 38MM SYNERGY DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DEVICE WAS FOUND ON SHELF WITH BOX CRUSHED, PACKAGING DAMAGED, AND BROKEN SEAL. THE INNER PACKAGE APPEARED INTACT BUT NOT SURE IF THE DEVICE WAS COMPROMISED INSIDE PACKAGING DUE TO OUTSIDE DAMAGE. STERILITY DID NOT APPEAR COMPROMISED. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SEAL COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885946 ↗
• MalfunctionFeb 10, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INSERTION, THE SHAFT BROKE OFF AT APPROXIMATELY MID SHAFT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13510324 ↗
• MalfunctionOct 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE IN A PERCUTANEOUS CORONARY INTERVENTION; HOWEVER, IT WAS NOTED THAT THE STENT CAME OUT OF THE PACKAGE WITH STRUTS BROKEN IN THE MIDDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12669059 ↗
• MalfunctionMay 6, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN A DIAGONAL ARTERY. A 2.25 X 38MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. DURING THE PROCEDURE, THE PHYSICIAN PULLED NEGATIVE ON THE DEVICE BEFORE DEPLOYMENT AND GOT BLOOD RETURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11788252 ↗
• MalfunctionDec 23, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 2.0 X 30MM EMERGE BALLOON, A 2.25 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11064374 ↗