SYNERGY™ XD H7493941808300Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729980940), received between Oct 19, 2021 and Feb 3, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 3.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE DURING AN INSERVICE FOR TECHNICIANS. THE STENT WAS PULLED OFF FROM THE DELIVERY CATHETER, SO ANOTHER DRUG ELUTING STENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254266 ↗
• MalfunctionOct 21, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 3.00 X 8 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY DELIVERING THE STENT, AND WHEN REMOVING IT FROM THE GUIDING CATHETER, THE STENT STRUTS WERE DAMAGED, CAUSING THE STENT TO FALL OFF THE BALLOON. THE PHYSICIAN THEN USED A NON-BOSTON SCIENTIFIC GUIDING EXTENSION. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495656 ↗
• InjuryFeb 9, 2024Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE PATIENT REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE MIDDLE OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS USED FOR TREATMENT. PRIOR TO INFLATION, THE STENT CAME OFF THE BALLOON. WHEN THE BALLOON WAS INFLATED TO SECURELY DEPLOY THE STENT INSIDE ANOTHER STENT, THE BALLOON RUPTURED. A NEW STENT WAS INSERTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681731 ↗
• MalfunctionFeb 2, 2024Break; Failure to Advance; Material Integrity Problem; Break; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. A SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT DEPLOYMENT SYSTEM SNAPPED, AND THE TIP WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18631968 ↗
• MalfunctionJul 28, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE DEVICE BROKE IN TWO IN THE MIDSHAFT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17414152 ↗
• MalfunctionAug 6, 2022Break; Difficult to Remove; Device Dislodged or Dislocated; Break; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 3.00 X 8MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE STENT MOUNTED ON THE BALLOON CATHETER BECAME STUCK IN THE CARRIER TUBE. THE BALLOON AND STENT BROKE OFF THE SYSTEM AS IT WAS BEING REMOVED FROM THE CARRIER TUBE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15180583 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.00 X 8MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE STENT SHAFT BROKE. THE DETACHED PORTION OF THE DEVICE WAS PULLED OUT AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657984 ↗