SYNERGY™ XD H7493941832500Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729981299), received between Dec 16, 2020 and Aug 29, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Nonstandard Device; Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Difficult to Advance; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI). A 5.00 X 32MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. DURING INSERTION, THE STENT FAILED TO ADVANCE IN THE 6FR NON-BOSTON SCIENTIFIC GUIDE CATHETER, AND IT WAS NOTED THAT THE STENT UNRAVELED FROM THE CATHETER. THE STENT DID REMAIN ON THE BALLOON WITH NO ISSUES TO THE PATIENT. A NON-BSC STENT WAS SUCCESSFULLY DEPLOYED TO TREAT THE LESION AND COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22929213 ↗
• MalfunctionFeb 10, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION. A 5.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND THE SHAFT BROKE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16350895 ↗
• MalfunctionFeb 8, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 5.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DELIVERY SYSTEM BROKE WHILE ATTEMPTING DEPLOYMENT. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16321685 ↗
• MalfunctionSep 23, 2021Deflation Problem; Failure to Advance; Deflation Problem; Failure to Advance

  IT WAS REPORTED THAT FAILURE TO DEFLATE WAS ENCOUNTERED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. A 5.00 X 32MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT THE STENT WAS UNABLE TO CROSS THE LESION. HOWEVER, IT WAS NOTED THAT THE BALLOON WOULD NOT DEFLATE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521395 ↗
• MalfunctionApr 28, 2021Material Separation; Material Separation

  IT WAS REPORTED THAT BALLOON TEAR OCCURRED. A 5.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS USED, HOWEVER; IT WAS NOTED THAT THE BALLOON WAS TORN OFF FROM THE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740757 ↗
• MalfunctionMar 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE BALLOON ALMOST DETACHED. DURING A PROCEDURE INVOLVING A 5.00 X 32MM SYNERGY XD IT WAS NOTED THAT THE BALLOON ALMOST DETACHED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11440434 ↗
• MalfunctionDec 16, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 5.00 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTICED THAT THERE WAS A BLOOD CAME BACK UP INTO THE ENDOFLATOR WHICH WAS ATTACHED TO THE MONORAIL PORTION OF THE STENT. WHEN THE DEVICE WAS PULLED OUT, A HOLE IN THE BALLOON PORTION OF THE STENT DELIVERY SYSTEM WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT AND NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE 80%-90% STENOSED, NON-TORTUOUS, ECCENTRIC TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11017916 ↗