SYNERGY™ XD H7493941832450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729981237), received between Jun 28, 2021 and May 15, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 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.

• MalfunctionMay 15, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. AFTER THE LESION WAS PRE-DILATED WITH GOOD EXPANSION, A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE CATHETER AND A NON-BSC GUIDEWIRE WERE USED. A 4.50 X 32 MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE PHYSICIAN ENCOUNTERED RESISTANCE DURING ADVANCEMENT IN THE PROXIMAL PORTION OF THE GUIDE JUST PAST THE TOUHY VALVE BUT WAS EVENTUALLY ABLE TO ADVANCE THE SYSTEM. THE STENT WAS SUCCESSFULLY DEPLOYED. DURING WITHDRAWAL OF THE DELIVERY SYSTEM FROM THE GUIDE, THE SHAFT BROKE IN HALF. THE ENTIRE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186857 ↗
• MalfunctionJan 20, 2026Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 4.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INFLATION, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY WITH NO FRAGMENTS LEFT, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. DURING INFLATION, CONTRAST FROM THE STENT BALLOON WAS COMING OUT FROM THE SHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24125310 ↗
• InjuryAug 1, 2025Break; Failure to Deflate; Break; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION FAILURE AND SHAFT BREAK OCCURRED RESULTING IN CARDIAC ARREST, ADDITIONAL INTERVENTION AND AN UNRETRIEVED DEVICE FRAGMENT. THE TARGET LESION WAS LOCATED IN THE CIRCUMFLEX ARTERY. A STENT WAS INITIALLY PLACED IN THE CIRCUMFLEX ARTERY, FOLLOWED BY A 4.50 X 32MM SYNERGY XD DRUG-ELUTING STENT PLACED IN THE CIRCUMFLEX ARTERY EXTENDING TO THE LEFT MAIN OSTIUM. AFTER DEPLOYMENT, THE BALLOON FAILED TO DEFLATE. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH THE INFLATION DEVICE. A HORNET 14 GUIDEWIRE WAS THEN USED TO ATTEMPT TO PUNCTURE THE BALLOON. ADDITIONALLY, THE BACK END OF THE BALLOON WAS CUT OFF IN AN ATTEMPT TO RELEASE THE PRESSURE. WHEN THE PHYSICIAN TRIED TO RETRACT THE BALLOON, THE BALLOON SHAFT BROKE, LEAVING THE BALLOON STUCK IN THE LEFT MAIN/CIRCUMFLEX ARTERY. THE PATIENT BECAME UNSTABLE AND EXPERIENCED CARDIAC ARREST AND A MINIMALLY INVASIVE, TEMPORARY HEART PUMP WAS PLACED. A SECOND PHYSICIAN SCRUBBED IN AND WAS ABLE TO ADVANCE A NON-BOSTON SCIENTIFIC GUIDEWIRE AND A MICROCATHETER PAST THE BALLOON TO THE DISTAL CIRCUMFLEX. THEN, A 2.0 BALLOON WAS ADVANCED AND WAS ABLE TO RESTORE FLOW. THE PHYSICIAN USED PROGRESSIVELY BIGGER

  Patient problems: Cardiac Arrest; Foreign Body In Patient

  MAUDE report 22690330 ↗
• InjuryMay 2, 2025Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 4.50 X 32 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT BALLOON FAILED TO INFLATE. WHILE ATTEMPTING TO REMOVE THE DEVICE, THE PHYSICIAN BROKE THE SHAFT. THE REMAINING COMPONENTS OF THE SHAFT AND BALLOON WERE SUCCESSFULLY RETRIEVED FROM THE PATIENTS BODY USING A SNARE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21952957 ↗
• MalfunctionJul 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN LEFT FEMORAL ARTERY. A 4.50 X 32MM SYNERGY XD WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION INTO THE GUIDE, THE CATHETER WAS BROKEN AND COULD NOT BE DELIVERED. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368503 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 4.50 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE INSERTION, THE SHAFT OF THE DELIVERY SYSTEM BROKE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081715 ↗