SYNERGY™ XD H7493941824270Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729980902), received between Dec 13, 2021 and Jan 5, 2026 — classified as 2 deaths, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Nonstandard Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 2.75 X 24MM SYNERGY? XD DRUG-ELUTING WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION, AND DIFFICULTY WAS ENCOUNTERED DURING REMOVAL. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23965384 ↗
• DeathApr 15, 2025Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH THE DEPLOYMENT OF A 2.75 X 24 MM SYNERGY XD DRUG-ELUTING STENT. DURING THE PROCEDURE, THE BALLOON SHAFT FRACTURED PROXIMAL TO THE MID-LEFT ANTERIOR DESCENDING (LAD) ARTERY POST-DEPLOYMENT. ALTHOUGH THE STENT WAS SUCCESSFULLY DEPLOYED, THE BALLOON COULD NOT BE REMOVED. THE FRACTURED DEVICE WAS EXTRACTED USING A SNARE. AFTER THE REMOVAL, THE PATIENTS CONDITION DETERIORATED RAPIDLY. A FULL CODE WAS INITIATED IN AN ATTEMPT TO STABILIZE THE PATIENT, BUT DESPITE ALL RESUSCITATIVE EFFORTS, THE PATIENT PASSED AWAY.

  Patient problems: Cardiac Arrest; Chest Pain; Insufficient Information; Respiratory Arrest

  MAUDE report 21840294 ↗
• DeathApr 8, 2025Break; Physical Resistance/Sticking

  PATIENT ARRIVED IN CATH LAB FOR A CARDIAC CATHETERIZATION. PROCEDURE BEGAN WITH ACCESS TO THE RIGHT GROIN AND DIAGNOSTIC IMAGING SHOWED A LESION IN THE PROXIMAL LAD. LESION WAS PREDILATED WITH A 2.0 X 20MM TAKERU BALLOON. A 2.75 X 24MM SYNERGY DES WAS THEN PASSED DOWN AND ACROSS THE LESION. STENT DEPLOYED TO 20 ATMS. UPON ATTEMPTED REMOVAL OF DELIVERY CATHETER, RESISTANCE WAS MET. CATHETER THEN RELEASED AND WAS REMOVED WHERE IT WAS NOTED THE CATHETER WAS BROKEN. ANGIOGRAPHY SHOWED THE BALLOON MARKERS WERE STILL IN THE VESSEL. PATIENT BEGAN TO COMPLAIN OF CHEST DISCOMFORT AND PATIENT WAS INTUBATED. VASCULAR SURGEON WAS CALLED TO ASSIST AND SUCCESSFULLY RETRIEVED BROKEN PIECE FROM BODY. PATIENT DISTRESS CONTINUED TO ESCALATE. CARDIAC AND RESPIRATORY ARREST SHORTLY FOLLOWED. CPR BEGAN AND ATTEMPTS TO PLACE AN IMPELLA DEVICE UNSUCCESSFUL. PATIENT EXPIRED IN CATH LAB.

  Patient problems: Cardiac Arrest; Chest Pain; Discomfort; Respiratory Arrest

  MAUDE report 21797169 ↗
• InjuryDec 6, 2022Inflation Problem; Difficult to Remove; Inflation Problem; Difficult to Remove

  IT WAS REPORTED THAT PATIENT VESSEL OBSTRUCTION OCCURRED. A PROCEDURE WAS BEING PERFORMED USING A SYNERGY XD MR US 2.75 X 24MM DEVICE FOR TREATMENT. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, IT WAS NOTED THAT THE BALLOON WAS ONLY ABLE TO INFLATE ABOUT HALFWAY. THE STENT WAS ABLE TO DEPLOY ON THE PROXIMAL END, BUT REMAINED ATTACHED TO THE BALLOON ON THE DISTAL END. UPON CLOSER INSPECTION, IT WAS NOTICED THAT THE STRUTS OF THE STENT WERE STUCK ON THE BALLOON. THE INDEFLATOR HAD LOST PRESSURE AND WAS NOTED TO BE SPINNING. UPON TRYING TO REMOVE THE STENT CATHETER USING MULTIPLE WAYS, INCLUDING INSERTING A NON-BOSTON SCIENTIFIC GUIDE EXTENSION CATHETER OVER THE BALLOON AND USING MANUAL FORCE TO DISLODGE THE STRUTS FROM THE BALLOON, THE DIAGONAL BRANCH SHUT DOWN AND LOST FLOW. THE PATIENT WAS THEN SENT TO SURGERY AND THE STENT WAS SUCCESSFULLY REMOVED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15925632 ↗
• MalfunctionNov 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED VIA USER/FACILITY MEDWATCH # 5113226 THAT BALLOON RUPTURE OCCURRED. A 2.75 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT BALLOON RUPTURED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866695 ↗
• InjuryNov 10, 2022Material Rupture

  STENT BALLOON RUPTURE DURING BALLOON ANGIOPLASTY. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789372 ↗
• MalfunctionJun 2, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 2.75 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE TIP OF 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 14579309 ↗
• MalfunctionDec 13, 2021Break; Break

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THIS 2.75X24MM SYNERGY XD WAS SELECTED, DURING INTRODUCTION THE SHAFT FRACTURED OUTSIDE THE BODY 10 INCHES FROM THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT, NOTHING WAS LEFT INSIDE THE BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983442 ↗