SYNERGY™ XD H7493941820500Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729981268), received between Jun 2, 2021 and Jan 8, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2025Material Rupture; Material Rupture

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT BALLOON RUPTURE OCCURRED. A 5.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE BALLOON FROM THE STENT WAS RUPTURED. THEN THE FRACTURE OF THE BALLOON SHAFT WHILE DELIVERING THE SECOND STENT REQUIRED TRAPPING AND SNARING OF THE STENT TO REMOVED FROM THE BODY. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. NO PATIENT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102266 ↗
• MalfunctionApr 19, 2024Entrapment of Device; Detachment of Device or Device Component; Failure to Deflate; Entrapment of Device; Detachment of Device or Device Component; Failure to Deflate

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT DEFLATION FAILURE, DEVICE ENTRAPMENT AND DEVICE DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 5.0 X 20 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. AFTER DEPLOYMENT OF THE STENT, THE BALLOON COULD NOT BE FULLY DEFLATED, CAUSING IT TO BECOME TRAPPED IN THE WIRE AND THE GUIDE. WHEN ATTEMPTING TO RETRIEVE THE STENT BALLOON, IT BROKE OFF FROM THE STENT DELIVERY SHAFT. NO FURTHER DETAILS WERE REPORTED IN RELATION TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19148043 ↗
• MalfunctionJun 30, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND SHAFT BREAK OCCURRED. A 5.00 X 20MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR SAPHENOUS VEIN GRAFT (SVG) PERCUTANEOUS CORONARY INTERVENTIONS (PCI) PROCEDURE. DURING THE PROCEDURE, THE BALLOON INFLATED AND STENT FULLY DEPLOYED AT 22 ATMOSPHERES. THE BALLOON BECAME STUCK ON THE GUIDE CATHETER WITHIN THE SVG AND WHEN THE PHYSICIAN ATTEMPTED TO REMOVE IT, THE CATHETER SHAFT FRACTURED AT THE GUIDEWIRE EXIT PORT. THE DEVICE WAS REMOVED AND THE PROCEDURE COMPLETED SUCCESSFULLY WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATIONS; THE PATIENT STATUS WAS STABLE AND THEY WERE DISCHARGED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875422 ↗
• InjuryJan 20, 2022Break; Fracture; Difficult to Remove; Break; Fracture; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES, DEVICE DETACHMENT AND ADDITIONAL INTERVENTION OCCURRED. A GUIDEZILLA II GUIDE EXTENSION CATHETER WAS ADVANCED TO THE TARGET LESION IN THE MID RIGHT CORONARY ARTERY (RCA) WHICH WAS NOTED TO BE VERY LARGE. A 5.00 X 20MM SYNERGY BALLOON EXPANDABLE STENT WAS ADVANCED AND THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE SYNERGY STENT DELIVERY SYSTEM BACK INTO THE GUIDEZILLA II, THE CATHETER BECAME STUCK. THE GUIDEZILLA II, SYNERGY DELIVERY SYSTEM CATHETER AND GUIDEWIRE WERE ALL REMOVED AS ONE UNIT. 8CM OF THE SYNERGY STENT DELIVERY SYSTEM BROKE OFF INSIDE THE PATIENT NEAR THE DISTAL SHEATH TIP. THE DETACHED PORTION WAS SUCCESSFULLY REMOVED USING A SNARE. THE PROCEDURE WAS COMPLETED AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13307937 ↗
• MalfunctionJul 1, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT DEFLATION FAILURE OCCURRED. THE 80%STENOSED TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED SAPHENOUS VEIN GRAFT. A 5.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED AT NOMINAL PRESSURE FOR TREATMENT. POST STENT DEPLOYMENT, IT WAS OBSERVED THAT THE BALLOON DID NOT DEFLATE PROPERLY AND THE BALLOON DID NOT REWRAP. AFTER THE BALLOON WAS DEFLATED FOR ONE MINUTE, AN ATTEMPT WAS MADE TO REMOVE THE BALLOON BUT IT WOULD NOT GO BACK INTO THE 6 FR GUIDE CATHETER. AN INDEFLATOR WAS ATTACHED AND PULLED NEGATIVE PRESSURE SEVERAL TIMES AND THE BALLOON WAS FINALLY PULLED BACK INTO THE GUIDE CATHETER AND REMOVED IN PARTIALLY INFLATED STATE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12105173 ↗
• MalfunctionJun 2, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 5.00 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE STENT STRUTS WERE LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE WITH NO ISSUES. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11926374 ↗