SYNERGY™ XD H7493941832270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729980926), received between Sep 23, 2021 and Sep 1, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported elevated cardiac enzymes and Myocardial Infarction occurred. The patient was on a prior regimen of Aspirin (>= 72 hours) and antiplatelet medication other than Aspirin (>= 72 hours). At the time of the procedure, the patient received Heparin or other antithrombotic medication. The 2.75 mm x 28 mm target lesion located in the main branch of the proximal left anterior descending vessel (LAD) was pretreated with three devices using the largest balloon diameter of 2.5 mm x 12 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and non-compliant balloon angioplasty catheter resulting in 30% residual stenosis and TIMI flow of 3. The lesion was then successfully treated with the 2.75 mm x 32 mm Synergy XD drug eluting stent achieving 0% residual stenosis with TIMI flow of 3. A balloon angioplasty catheter (PTCA dilatation catheter) and a non-complaint balloon was used for post dilation as ancillary devices. The 2.5 mm x 20 mm target lesion located in the side branch of the 1st diagonal vessel was pretreated with three devices using the largest balloon diameter of 2.5 mm x 15 mm Wolverine cutting balloon, semi-compliant balloon angioplasty catheter and

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 50550385 ↗
• MalfunctionMay 9, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WITHIN THE PATIENT ANATOMY WHEN ATTEMPTING TO PULL THE STENT AND CATHETER BACK OUT AND DECIDED NOT TO DEPLOY THE STENT. THE BALLOON WAS IN FULLY DEFLATED STATE AND WAS REMOVED FROM THE PATIENT IN ONE PIECE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21998870 ↗
• InjuryJun 29, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WITH IN-STENT RESTENOSIS WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION WITH A 2.5X20MM BALLOON CATHETER, A 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE MIDDLE OF THE SHAFT FRACTURED. THE DEVICE WAS REMOVED BY SNARING, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17233475 ↗
• MalfunctionApr 6, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, IT WAS DIFFICULT TO ADVANCE OVER THE NON-BOSTON SCIENTIFIC (BSC) WIRE AND IT WOULD NOT ENTER INTO THE SHEATH. DURING REMOVAL, IT WAS DIFFICULT TO REMOVE FROM THE WIRE AND SHAFT KINK WAS NOTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693654 ↗
• MalfunctionNov 30, 2021Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-NOV-2021 IT WAS REPORTED THAT SHAFT BREAK AT THE HUB OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT IT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED INTACT FROM THE PATIENT'S BODY. AFTER FURTHER LESION PREPARATION, THE DEVICE WAS PREPARED FOR REINTRODUCTION BUT THE SHAFT BROKE AT THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A BREAK 41.1CM DISTAL TO THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12898842 ↗
• MalfunctionOct 5, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE PROXIMAL SHAFT BROKE. THE DEVICE WAS PULLED BY THE PHYSICIAN FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A 2.75X34MM NON-BOSTON SCIENTIFIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12576786 ↗
• MalfunctionSep 23, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT AND STENT DAMAGE OCCURRED. THE 2.75 X 32MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT LOOKED LIKE IT WAS PARTLY OFF THE DELIVERY SYSTEM AND DAMAGED. 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 12521448 ↗