SYNERGY™ XD H7493941816500Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729981251), received between Aug 7, 2022 and Sep 30, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Rupture

  It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the mildly tortuous and mildly calcified coronary artery. A 5.00 x 16mm Synergy XD drug-eluting stent (DES) was advanced for treatment. However, during initial inflation at 10 atmospheres, the balloon ruptured. The device was removed, and the procedure was completed with another of same device. There were no patient complications reported, and the patient was stable following the procedure.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947819 ↗
• MalfunctionDec 5, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 16MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT BROKE WHILE ENTERING THE PATIENT. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729892 ↗
• MalfunctionDec 5, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 16MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT BROKE WHILE ENTERING THE PATIENT. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729558 ↗
• InjuryNov 27, 2024Device-Device Incompatibility; Migration; Device-Device Incompatibility; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED WHICH REQUIRED INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. FOLLOWING A PRE-INTRAVASCULAR ULTRASOUND (IVUS) ON THE LESION, A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, WHEN THE PHYSICIAN BALLOONED THE STENT WITH A NON-COMPLIANT BALLOON, IT WAS OBSERVED THAT THE STENT MOVED FROM THE ORIGINAL POSITION WITHIN THE VESSEL. SUBSEQUENTLY, THE STENT WAS POST DILATED AND DEPLOYED ANOTHER SYNERGY STENT MORE PROXIMALLY TO COVER THE AREA THAT WAS MISSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798261 ↗
• MalfunctionApr 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE DISTAL TIP OF THE STENT LOOKED BENT AND FRACTURED. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19028454 ↗
• MalfunctionMar 5, 2024Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT DEFLATION ISSUE OCCURRED. A 5.00 X 16MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON DEFLATED SLOWER THAN NORMAL. THE BALLOON WAS REMOVED IN A PARTIALLY INFLATED STATE, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841290 ↗
• InjuryMar 16, 2023Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  IT WAS REPORTED VIA MAUDE REPORT MW5114904 THAT BALLOON DIFFICULTY REMOVAL AND DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN RIGHT CORONARY ARTERY (RCA). A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, POST DEPLOYMENT, THE BALLOON WOULD NOT PULL BACK INTO THE GUIDE CATHETER. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE AND REMOVE THE BALLOON AND WIRE. IT WAS NOTED THAT THE STENT BALLOON WAS DETACHED FROM THE CATHETER AND A SMALL SEGMENT OF THE BALLOON MARKER ALSO DETACHED FROM THE BALLOON AND WAS UNABLE TO BE RETRIEVED FROM THE RCA. THE PHYSICIAN WAS ABLE TO RETRIEVE THE SEVERED BALLOON, UTILIZING THE PATIENT'S FEMORAL VEIN, AS THE BALLOON HAD MIGRATED BELOW THE PATIENT'S KNEE. THE SMALL PORTION OF THE BALLOON MARKER DID NOT REQUIRE ADDITIONAL ATTEMPTS TO REMOVE IT AS IT IS VERY SMALL, AND THE PATIENT WILL BE TREATED MEDICALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16552115 ↗
• MalfunctionNov 14, 2022Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. DURING THE STENT DELIVERY SYSTEM REMOVAL, IT WAS RESISTANCE WAS FELT AS THE STENT DELIVERY SYSTEM WAS BEING REMOVED THROUGH THE GUIDE CATHETER. THE STENT DELIVERY SYSTEM SHAFT BROKE AT A LOCATION OUTSIDE OF THE PATIENT DURING REMOVAL. BOTH THE STENT BALLOON AND THE WIRE WERE PULLED OUT AS A UNIT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788621 ↗
• InjuryAug 7, 2022Difficult to Remove; Material Separation; Detachment of Device or Device Component; Activation Failure; Difficult to Remove; Material Separation; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT DISTAL CATHETER SHAFT SEPARATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, WHEN THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM (SDS), RESISTANCE WAS FELT. THE PHYSICIAN PULLED THE DEVICE AND NOTICED ON FLUOROSCOPY THAT THE SDS BALLOON REMAINED IN THE ARTERY. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED SDS BALLOON THROUGH SNARE, RE-WIRE AND PERFORMED ANTEGRADE DISSECTION REENTRY TECHNIQUE BUT WAS UNSUCCESSFUL. A SURGERY WAS SCHEDULED IN 30 DAYS TO REMOVE THE DETACHED COMPONENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: Foreign Body In Patient; Stroke/CVA

  MAUDE report 15180693 ↗
• MalfunctionAug 7, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN SEVERELY CALCIFIED CIRCUMFLEX ARTERY. A 5.00 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE SHAFT BROKE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180688 ↗