SYNERGY™ XD H7493941824250Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729980827), received between Mar 11, 2021 and Sep 1, 2026 — classified as 1 death, 6 injuries, 11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50551622 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported elevated cardiac enzymes and Myocardial Infarction occurred. The patient was on a prior regimen of Aspirin (>= 72 hours) and antiplatelet medication other than Aspirin (>= 72 hours). At the time of the procedure, the patient received Heparin or other antithrombotic medication. The 2.75 mm x 28 mm target lesion located in the main branch of the proximal left anterior descending vessel (LAD) was pretreated with three devices using the largest balloon diameter of 2.5 mm x 12 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was then successfully treated with the 2.75 mm x 32 mm Synergy XD drug eluting stent achieving 0% residual stenosis with TIMI flow of 3. A balloon angioplasty catheter (PTCA dilatation catheter) and a non-complaint balloon was used for post dilation as ancillary devices. The 2.5 mm x 20 mm target lesion located in the side branch of the 1st diagonal vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50550334 ↗
• InjuryJan 22, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED RESULTING TO ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND VERY CALCIFIED VESSEL. AS THE 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCING DISTALLY TOWARDS THE LESION, THE STENT CAME OFF THE BALLOON. DIFFERENT METHODS WERE PERFORMED TO RETRIEVE THE DEVICE INCLUDING THE USE OF A SNARE, BUT THE PHYSICIAN ENDED UP MANUALLY PUSHING THE STENT TO THE LESION. THE STENT WAS INFLATED AND DEPLOYED JUST PROXIMAL TO THE LESION TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145712 ↗
• MalfunctionFeb 25, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. FOLLOWING STENT DEPLOYMENT, THE BALLOON WAS INFLATED TO NOMINAL ATMOSPHERES FOR 15 SECONDS. UPON RETRACTION, IT WAS DIFFICULT TO REMOVE THE BALLOON FROM THE STENT. THE BALLOON WAS THEN REINFLATED WITHIN THE DEPLOYED STENT AND DEFLATED AGAIN FOR 10 SECONDS, BUT THE BALLOON COULD NOT BE PULLED BACK WITHOUT THE GUIDE BEING SUCKED INTO THE VESSEL AN EXTREME AMOUNT. THE DEVICE WAS REMOVED WITH GREAT FORCE IN ONE PIECE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21463399 ↗
• MalfunctionMay 30, 2024Break; Positioning Failure; Failure to Advance; Break; Positioning Failure; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT COULD NOT ADVANCE ACROSS THE LESION. AN ADDITIONAL BALLOON WAS USED TO PREDILATE THE LESION AGAIN. A LONGER STENT WAS INSERTED INTO THE LESION, BUT IT ALSO COULD NOT ADVANCE. A GUIDEZILLA CATHETER WAS THEN USED TO FACILITATE PASSAGE THROUGH THE VESSEL. THE STENT WAS RE-INSERTED AND SUCCESSFULLY CROSSED THE LESION. HOWEVER, UPON ATTEMPTING TO INFLATE THE BALLOON TO EXPAND THE STENT, THE INDEFLATOR DID NOT REGISTER ANY PRESSURE AND THE STENT COULD NOT BE DEPLOYED. WHEN THE STENT WAS BEING REMOVED, IT DETACHED WITHIN THE HEMOSTASIS VALVE, ABOUT 1/3 FROM THE DISTAL END OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19428354 ↗
• MalfunctionApr 15, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED. DURING PREPARATION, IT WAS OBSERVED THAT THE STENT STRUTS WERE DAMAGED, THE SHAFT WAS KINKED AND THE SENT CAME OFF OF THE BALLOON. THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19111566 ↗
• InjuryJan 12, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE PATIENT AND ADDITIONAL INTERVENTION WAS REQUIRED FOR RETRIEVAL. A 2.50 X 24 MM SYNERGY XD WAS SELECTED FOR USE. THE DEVICE WAS ADVANCED AND POSITIONED TO CROSS THE LESION, BUT THE STENT WOULD NOT CROSS. WHEN ATTEMPTING TO REMOVE THE DEVICE UNDEPLOYED, THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND REMAINED POSITIONED BETWEEN THE RIGHT CORONARY ARTERY AND AORTIC OSTIUM. DUE TO THE LOCATION OF THE DISLODGEMENT, THE STENT WAS NOT RECOVERABLE. THE STENT WAS CRUSHED INTO PLACE DURING A SUBSEQUENT PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18504511 ↗
• MalfunctionAug 8, 2022Break; Difficult to Advance; Material Deformation; Break; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WOULD NOT PASS THROUGH THE HEMOSTASIS VALVE ON THE GUIDE CAUSING THE STENT TO CRUMBLE UP AND BREAK. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15187986 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE FRONT OF THE DELIVERY SHAFT BROKE WHILE PULLING STYLET OUT OF THE STENT. 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 14469878 ↗
• MalfunctionMay 12, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND IT WAS NOTICED THAT THE STENT STRUT WAS BENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14377664 ↗
• InjuryMay 4, 2022Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND MILDLY CALCIFIED BIFURCATED REGION OF THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. CALCIFIC NODULES WERE PRESENT. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED FOR TREATMENT. HOWEVER, FOLLOWING STENT DEPLOYMENT, INTRAVASCULAR ULTRASOUND (IVUS) REVEALED BROKEN STRUTS. A SECOND STENT WAS DEPLOYED IN THE BROKEN STENT AND THE PROCEDURE WAS COMPLETED WITH POST DILATATION. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274697 ↗
• MalfunctionMay 4, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT WAS CRACKED CAUSING BLOOD TO RETURN INTO THE INDEFLATOR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274621 ↗
• 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 13087780 ↗
• MalfunctionAug 16, 2021Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.50 X 24MM SYNERGY DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE SHAFT BROKE. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12325243 ↗
• MalfunctionAug 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE CROSSING THE LESION, IT WAS NOTICED THAT THE STENT TWISTED OR CRUSHED INSIDE THE ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. IT WAS FURTHER REPORTED THAT THE STENT STRUT WAS DAMAGED AND IT WAS REMOVED THROUGH THE GUIDE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310866 ↗
• MalfunctionJun 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE PROXIMAL END OF THE STENT APPEARED TO BE FRAYED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. 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 12038095 ↗
• MalfunctionMay 10, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED CIRCUMFLEX ARTERY. A 2.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR USE. HOWEVER, THE PROXIMAL SHAFT BROKE WHILE TRYING TO ADVANCE THE STENT. THE LOCATION OF THE FRACTURE WAS OUTSIDE OF THE PATIENT. THE DEVICE WAS COMPLETELY REMOVED BY PULLING OUT THE DISTAL PART 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 11797847 ↗
• InjuryMar 11, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS MID RIGHT CORONARY ARTERY (RCA) WHICH HAD MODERATE ANGULATION. PRE-DILATATION WAS PERFORMED WITH EMERGE AND NC EMERGE BALLOON CATHETERS. THE PHYSICIAN THEN DELIVERED 2.50 X 16 MM AND 2.50 X 24 MM SYERGY XD STENTS WITH THE AID OF A 6F GUIDEZILLA EXTENSION CATHETER. BOTH STENTS WERE DEPLOYED WITHOUT ANY ISSUES AND POST-DILATATION WAS PERFORMED USING A 2.50 X 12 MM NC EMERGE BALLOON CATHETER. THE PATIENT WAS GIVEN 180MG BRILINTA MEDICATION AND TRANSFERRED TO THE RECOVERY AREA. AN HOUR LATER, THE PATIENT EXPERIENCED HYPERTENSION AND CHEST PAIN. AN ANGIOGRAM WAS PERFORMED WHICH REVEALED THROMBUS WITHIN BOTH STENTS WHICH WAS EVACUATED USING A NON BOSTON SCIENTIFIC DEVICE. POST-DILATATION WAS PERFORMED AGAIN WITH A 2.50 X 12 MM NC EMERGE BALLOON AND TIMI 3 FLOW WAS RESTORED. THE PATIENT FULLY RECOVERED.

  Patient problems: Chest Pain; High Blood Pressure/ Hypertension; Thrombosis/Thrombus

  MAUDE report 11463961 ↗