SYNERGY™ XD H7493941828400Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729981152), received between Jun 9, 2021 and May 7, 2026 — classified as 3 injuries, 7 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 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.

• MalfunctionMay 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING THE PREPARATION, A 4.00 X 28MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR USED. HOWEVER, IT WAS NOTICED THAT THE STENT DID FELL OFF OF THE BALLOON PRIOR TO INSERTION OF GUIDEWIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25116550 ↗
• MalfunctionOct 3, 2024Device Dislodged or Dislocated; Material Deformation; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. A 4.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THE STENT LOOKED MANGLED AND WAS PARTIALLY OFF THE SHAFT WHEN IT WAS REMOVED FROM THE HOOP. THE STENT WAS PUT ASIDE, AND A REPLACEMENT STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20358802 ↗
• MalfunctionJan 24, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 4.00 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE SHAFT BROKE DURING INSERTION. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18570238 ↗
• InjuryJan 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS REMOVED, IT WAS FOUND THAT THE BALLOON REMAINED IN THE PATIENT'S BODY. THE DETACHED COMPONENT WAS REMOVED TOGETHER WITH THE GUIDEWIRE AND GUIDE CATHETER; HOWEVER, THE EVENT CAUSED ADDITIONAL PROCEDURE TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13183076 ↗
• MalfunctionOct 15, 2021Fracture; Device-Device Incompatibility; Fracture; Device-Device Incompatibility

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 80% STENOSED TARGET LESION WAS LOCATED AT THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN (LM) ARTERY. A 4.00 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED AND IMPLANTED FOR TREATMENT. FOLLOWING POST-DILATATION OF A KISSING BALLOON CATHETER OF THE LM TO LEFT ANTERIOR DESCENDING/ CIRCUMFLEX AND PROXIMAL OPTIMISATION TECHNIQUE (POT) OF THE LM, THE MID PORTION OF THE SYNERGY STENT WAS FRACTURED AND DEFORMED UNDER FLOUROSCOPY. THERE WAS NO INTERVENTION DONE TO CORRECT THE FRACTURED STENT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642766 ↗
• InjuryOct 7, 2021Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation; Device-Device Incompatibility; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 28MM SYNERGY XD DRUG-ELUING STENT WAS ADVANCED FOR TREATMENT USING A 6F NON-BOSTON SCIENTIFIC EXTENSION GUIDE CATHETER. HOWEVER, UPON ENTRY INTO THE VESSEL, THE GUIDE AND THE EXTENSION GUIDE CATHETER BACKED OUT OF THE ARTERY WITH THE STENT REMAINING AT THE OSTIUM. WHILE ATTEMPTING TO RESEAT THE GUIDE AND EXTENSION GUIDE CATHETER, THE DEVICE SHEARED THE STENT OFF OF THE BALLOON REQUIRING A VASCULAR SURGEON TO SNARE IT. THE DETACHED PORTION WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 4.0X32 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12593962 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 28MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE HYPOTUBE BROKE IN HALF DURING DELIVERY OF THE DEVICE. THE DEVICE WAS REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED WITH A WITH 4.00 X 28MM STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12416100 ↗
• InjuryAug 17, 2021Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT STENT DAMAGE POST DEPLOYMENT OCCURRED AND THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT MAIN (LM) TO LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED IN THE LESION SITE ON JULY 26TH. ONE DAY AFTER THE PROCEDURE, THE PATIENT BECAME UNSTABLE IN INTENSIVE CARE UNIT (ICU), BROUGHT BACK TO CATH LAB AND FOUND A CLOT IN THE MID LAD FROM A STENT DEPLOYED A YEAR AGO. THE PHYSICIAN CONVERTED TO PERCUTANEOUS CORONARY INTERVENTION (PCI) AFTER ANGIOGRAM; HOWEVER, HE FELT THE GUIDE WIRE WAS BEHIND THE STENT STRUTS. THUS, ATTEMPTED INTRAVASCULAR ULTRASOUND (IVUS) AND NOTED THAT GUIDE WIRE HAD CAUSED THE STENT DEFORMATION. THE PROCEDURE WAS COMPLETED BY BALLOONING, PLACED A 4.0X38 NON-BSC STENT AND PLACED AN ECMO PERFUSION CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 12330778 ↗
• MalfunctionJul 21, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO CROSS THE LESION, THE SHAFT WAS FRACTURED. THE PHYSICIAN REMOVED THE DEVICE INTACT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202320 ↗
• MalfunctionJun 9, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON REMOVAL OF THE DEVICE FROM THE PATIENT, THE SHAFT BROKE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE SHAFT BROKE IN THE MIDDLE AND THE BROKEN PART WAS JUST PULLED OUT WITHOUT PROBLEM. THE PROCEDURE WAS COMPLETED USING A DIFFERENT STENT. THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964516 ↗