SYNERGY™ XD H7493941848270Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 08714729985211), received between Feb 18, 2021 and Mar 9, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• MalfunctionMar 9, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. UPON UNPACKING OF A 2.75 X 48MM SYNERGY? XD DRUG-ELUTING STENT, IT WAS NOTICED THAT THE DISTAL EDGE OF STENT WAS NOT FULLY ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548009 ↗
• MalfunctionDec 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS NO LONGER CENTERED ON THE BALLOON WHEN IT WAS OPENED IN THE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833066 ↗
• MalfunctionJan 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. A 2.75 X 48MM SYNERGY XD WAS SELECTED FOR USE. DURING INSERTION, THE STENT GOT CAUGHT AND DISLODGED IN THE WATCHDOG WHEN THE STENT WAS INSERT THROUGH A WATCHDOG DEVICE OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER WATCHDOG AND STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432212 ↗
• MalfunctionNov 16, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. DURING UNPACKING OF A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT (DES), IT WAS NOTED THAT THE STENT WAS HALFWAY OFF THE BALLOON AND WAS STRETCHED OUT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SYNERGY XD DES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18152301 ↗
• InjuryApr 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE AND CARDIAC ARREST OCCURRED REQUIRING RESUSCITATION AND ADDITIONAL INTERVENTION. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE NON-TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED. HOWEVER, AFTER REMOVING THE POST-DILATATION BALLOON CATHETER, A STENT FRACTURE WAS OBSERVED. A ROTABLATOR WAS SUBSEQUENTLY USED TO GAIN ACCESS AS THE DEVICES COULD NOT PASS, AND ANOTHER STENT WAS PLACED. DURING THE PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST. THE PATIENT WAS RESUSCITATED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 16714740 ↗
• MalfunctionOct 12, 2022Device Markings/Labelling Problem; Wrong Label; Device Markings/Labelling Problem; Wrong Label

  IT WAS REPORTED THAT IMPROPER LABELING OCCURRED. A 2.75MM X 48MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE SIZE OF THE STENT WITHIN THE BOX WAS INCORRECT. THE BOX WAS LABELED FOR 2.75MM X 48MM SYNERGY XD; HOWEVER, THE HUB OF THE DEVICE WAS LABELLED 2.75MM X 38MM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588925 ↗
• MalfunctionFeb 8, 2022Positioning Failure; Inflation Problem; Material Rupture; Positioning Failure; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A BALLOON RUPTURED OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. THE LESION WAS PRE-DILATED. A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED WITHOUT RESISTANCE OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE FOR TREATMENT. UPON ATTEMPTING TO DEPLOY THE STENT, IT WAS NOTED THAT THAT IT WAS LOSING PRESSURE AT 7 ATMOSPHERES FOR 5 SECONDS AND THE STENT FAILED TO DEPLOY. THERE WAS BLOOD RETURN IN THE INFLATION DEVICE. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE BALLOON WAS FAILED TO INFLATE AND WAS NOT RUPTURED AS WHAT PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480337 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, AFTER OPENING THE STENT, A PORTION OF THE STENT ITSELF WAS HANGING OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282824 ↗
• InjuryJan 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA FACILITY MEDWATCH THAT STENT DISLODGEMENT INSIDE THE PATIENT OCCURRED. AS A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS BEING ADVANCED FOR TREATMENT WHEN A PORTION OF THE STENT CAME OFF OF BALLOON-STYLETTE REMOVED FROM BALLOON EASILY . UNFORTUNATELY, DEVICE WAS NOT SAVED. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13252638 ↗
• MalfunctionFeb 18, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED RIGHT CORONARY ARTERY. A 2.75 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. HOWEVER, UPON REMOVAL, THE PROXIMAL STENT CAME INTO CONTACT WITH THE NON-BOSTON SCIENTIFIC GUIDE CATHETER AND CAUSED THE VERY PROXIMAL PORTION OF THE STENT STRUT TO BE MANGLED AND DAMAGED. THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343020 ↗