SYNERGY™ XD H7493941820450Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729981206), received between Jun 7, 2021 and Jan 23, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE WHILE PLACING THE STENT AT THE LESION, THE STENT DELIVERY SYSTEM WAS SNAPPED IN HALF. THE DEVICE WAS REMOVED WITHOUT INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21223774 ↗
• MalfunctionJul 17, 2024Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DIFFICULTY REMOVAL, DEFLATION FAILURE AND SHAFT BREAK OCCURRED. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 4.50 X 20 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED AT THE LESION SITE. AFTER DEPLOYMENT, THE DELIVERY SYSTEM BALLOON FAILED TO DEFLATE PROPERLY, RESULTING IN DIFFICULTY REMOVING THE DEVICE FROM THE VESSEL. IMAGING SHOWED NO CONTRAST INSIDE THE BALLOON. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM FROM BY WITHDRAWING IT THROUGH THE GUIDE CATHETER, UNSUCCESSFULLY. THE DELIVERY SYSTEM AND GUIDE CATHETER WERE REMOVED TOGETHER AND UPON OBSERVATION, THE BALLOON APPEARED DETACHED FROM THE DELIVERY SYSTEM INSIDE THE GUIDE. AN ADDITIONAL GUIDE CATHETER WAS INSERTED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767102 ↗
• MalfunctionJun 20, 2024

  DURING THE CARDIAC PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, THE STENT BALLOON, EMERGE MONORAIL BALLOON (2.5MM X 15MM), LOT # 32767500, EXPIRATION 7/3/2026, BROKE OFF FROM ITS DEPLOYMENT SHAFT, AFTER ITS SUCCESSFUL STENT DEPLOYMENT. THE BALLOON BROKE OFF WHILE BEING REMOVED FROM THE PATIENT, AND REMAINED SEATED INSIDE THE GUIDING CATHETER. AFTER OBSERVING THE PARTIALLY BROKEN SHAFT, THE BALLOON WAS VISUALIZED IN THE GUIDING CATHETER USING FLUOROSCOPY AND WAS PROMPTLY REMOVED. SECOND SYNERGY XD DRUG-ELUTING SYSTEM WAS USED (31990123) TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574225 ↗
• MalfunctionOct 18, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED VIA FACILITY MEDWATCH #(B)(4) THAT CATHETER ENTRAPMENT ON GUIDEWIRE AND SHAFT BREAK OCCURRED. A 4.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING REMOVAL, THE BALLOON GOT STUCK ON THE WIRE AND COULD NOT BE REMOVED. IT WAS ALSO NOTICED THAT THE BALLOON SHAFT SNAPPED AND BROKE. THE BALLOON WAS PULLED TOGETHER WITH THE WIRE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17962218 ↗
• MalfunctionOct 3, 2023

  ELDERLY FEMALE WITH HISTORY OF DIABETES MELLITUS, HYPERTENSION, CORONARY ARTERY DISEASE AND RECENT SHORTNESS OF BREATH AND INTERMITTENT CHEST PAIN. PROCEDURE: PERCUTANEOUS INTERVENTION. THE BALLOON STUCK TO THE WIRE- SHAFT OF CATHETER SNAPPED. ALL REMOVED WITHOUT KNOWN HARM TO PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY XD (PER SITE REPORTER) WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17859986 ↗
• MalfunctionApr 13, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED OBTUSE MARGINAL BRANCH. A 4.50 X 20MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, WHILE STILL OUTSIDE OF THE BODY, THE STENT DELIVERY SYSTEM WAS SHEARED OFF/FRACTURED. THE DEVICE WAS PULLED TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14107642 ↗
• MalfunctionJan 28, 2022Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A PERCUTANEOUS CORONARY INTERVENTION WAS BEING PERFORMED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 4.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, RESISTANCE WAS MET IN THE VESSEL RIGHT AS THE STENT EXITED THE GUIDE CATHETER. THE PHYSICIAN PUSHED AND PULLED THE DEVICE AND NOTICED THAT THE HYPOTUBE CAME OUT WITHOUT THE DISTAL PART OF THE DELIVERY SYSTEM. THE ENTIRE SYSTEM WAS REMOVED ALTOGETHER TO RETRIEVE THE BROKEN PART OF THE SHAFT. A 4.50 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT MET THE SAME RESISTANCE AND THE SHAFT WAS BENT BUT DID NOT BREAK. THE PHYSICIAN TRIED ONE MORE BALLOON WHICH DID NOT CROSS SO THE PROCEDURE WAS STOPPED AND THE PATIENT WAS SENT TO SURGERY. NO PATIENT COMPLICATIONS RELATED TO THE TWO STENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13385591 ↗
• MalfunctionJun 7, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.50 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE; HOWEVER, IT WAS NOTED THAT THE STENT WAS FLARED OUT OF HOOP. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952246 ↗