SYNERGY™ XD H7493941824350Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729981060), received between Jun 1, 2021 and May 4, 2026 — classified as 1 death, 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Break; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT DEVICE ISSUES OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. FOLLOWING PRE-DILATION WITH A 3 X 12MM NON-BSC LITHOTRIPSY BALLOON, A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED FOR TREATMENT, BUT RESISTANCE WAS FELT. AS THE STENT DELIVERY SYSTEM WAS ADVANCING THROUGH THE GUIDE CATHETER, THE SHAFT BROKE AND THE STENT WAS STUCK IN THE GUIDE. THE STENT WAS ABLE TO BE TRAPPED IN THE GUIDE CATHETER, AND EVERYTHING WAS REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25069030 ↗
• InjuryFeb 26, 2026Nonstandard Device; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLODGMENT OCCURRED RESULTING IN ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). FOLLOWING PRE-DILATION WITH A 2.50 X 15 MM EMERGE BALLOON CATHETER, THE 3.50 X 24 MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT WAS UNABLE TO CROSS THE LESION. A 3.50 X 15 MM NC EMERGE WAS THEN USED TO PRE-DILATE THE RCA ALONG WITH A NON-BOSTON SCIENTIFIC (NON-BSC) GUIDE EXTENSION CATHETER FOR BETTER SUPPORT. THE 3.50 X 24 MM SYNERGY XD WAS RE-INTRODUCED BUT WAS STILL UNABLE TO CROSS THE LESION. DURING RETRIEVAL, THE STENT DELIVERY SYSTEM (SDS) WAS DIFFICULT TO REMOVE. THE DEVICE LOOKED TO BE BUCKLING PROXIMALLY ON THE DISEASED VESSEL OR THE GUIDE CATHETER, AND THE DISTAL END OF THE STENT APPEARED TO BE OFF THE BALLOON. WHEN THE SDS WAS EVENTUALLY REMOVED AND WAS INSPECTED, THERE WAS NO STENT ON THE BALLOON. THE UNDEPLOYED STENT WAS VISIBLE IN THE PROXIMAL RCA, LODGED IN THE DISEASED VESSEL. A 3.50 X 15 MM NC EMERGE BALLOON WAS USED TO FURTHER PRE-DILATE THE VESSEL AND EMBED THE UNEXPANDED STENT IN THE VESSEL WALL. A 3.50 X 28 MM SYNERGY XD WAS ADVANCED DOWN THE RCA AND DEPLOYED. THE RCA WAS PATENT AND THE UNEXPANDED 3.50 X 24 MM SYNE

  Patient problems: Foreign Body In Patient

  MAUDE report 24463811 ↗
• MalfunctionFeb 6, 2026Nonstandard Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, AFTER ADVANCING THE STENT THROUGH THE GUIDE, THE PHYSICIAN NOTICED THE STENT MOVED ON THE BALLOON. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24282956 ↗
• InjuryMay 27, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT SHAFT BREAK AND BALLOON DETACHMENT OCCURRED RESULTING IN SURGICAL INTERVENTION. THE TARGET LESIONS WERE LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA), LEFT ANTERIOR DESCENDING ARTERY (LAD), AND LEFT CIRCUMFLEX ARTERY (LCX). AFTER A 7F NON-BOSTON SCIENTIFIC (BSC) SHEATH WAS INSERTED WITHIN THE EXISTING IMPELLA SHEATH USING A SINGLE-ACCESS TECHNIQUE, A 7F NON-BSC GUIDE CATHETER WAS ADVANCED IN THE OSTIUM OF LMCA. THEN, TWO SEPARATE NON-BSC GUIDEWIRES WERE ADVANCED INTO THE LCX AND LAD, AND PRE-DILATED THE LESIONS WITH 2.5MM NC EMERGE BALLOON CATHETERS. FOLLOWING PRE-DILATION, AN INTRAVASCULAR LITHOTRIPSY WAS PERFORMED USING A 3.0 X 12MM SHOCKWAVE BALLOON TO TREAT THE LMCA AND LAD. SUBSEQUENTLY, A 3.5X28MM SYNERGY DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE OSTIAL LMCA TO PROXIMAL LAD, FOLLOWED BY 3.50 X 24MM SYNERGY XD DES IN THE OSTIAL LMCA TO PROXIMAL LCX. THESE WERE POST-DILATED AT HIGH PRESSURE AND FINISHED WITH SIMULTANEOUS KISSING BALLOON INFLATION TO ACHIEVE A FINAL LMCA DIAMETER OF 6 MM. THE FINAL RESULT SHOWED EXCELLENT BLOOD FLOW (TIMI 3), WITH NO RESIDUAL NARROWING, DISSECTIONS, BLOCKAGES, OR COMPLICATIONS, AND THE PATIENT WAS NOT SUITABLE FOR ATHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22089539 ↗
• MalfunctionFeb 5, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING INFLATION UNDER NEGATIVE PRESSURE, A BLOOD LEAK WAS NOTICED IN THE INDEFLATOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309835 ↗
• DeathDec 10, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT DIED. THE PATIENT PRESENTED FOR MULTIVESSEL PERCUTANEOUS CORONARY INTERVENTION WITH A NON-BOSTON SCIENTIFIC (BSC) HEART PUMP IN USE. THE 80 TO 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A ROTAPRO AND A NON-BSC LITHOTRIPSY BALLOON WERE UTILIZED WITH NO PATIENT ISSUES. SEVEN STENTS WERE DEPLOYED WITH NO PATIENT COMPLICATIONS. A 3.50 X 24 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED, AND AFTERWARD, THE PHYSICIAN INSTRUCTED THE TECHNICIAN TO INFLATE THE STENT DELIVERY SYSTEM BALLOON TO 30 ATM BEFORE REMOVING THE SYSTEM. THE BALLOON WAS INFLATED FOR 20 SECONDS AND THEN FULLY DEFLATED AFTER ABOUT 5 SECONDS. DURING REMOVAL, THE HYPOTUBE OR BALLOON GOT STUCK. RESISTANCE WAS ENCOUNTERED AND THE DEVICE WAS REMOVED WITH FORCE CAUSING THE HYPOTUBE TO SNAP INSIDE THE PATIENT. BALLOON MARKERBANDS SHOWED THAT A PORTION OF THE HYPOTUBE WAS SITTING BETWEEN THE LEFT MAIN AND AORTA. FOLLOWING CONSULTATION WITH A SURGEON, THE DECISION WAS MADE TO ATTEMPT TO RETRIEVE THE DEVICE FRAGMENT WITH A SNARE. ANESTHESIA WAS CALLED TO INTUBATE THE PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE FRAGMENT BEFOR

  Patient problems: Foreign Body In Patient

  MAUDE report 20894761 ↗
• MalfunctionAug 16, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE CHRONIC TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE STENT WOULD NOT CROSS THE LESION. DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE SHAFT BROKE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17561385 ↗
• MalfunctionAug 16, 2023Difficult to Remove; Failure to Deflate; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED AND DEPLOYED USING A 5F JR4 GUIDE CATHETER. HOWEVER, DURING REMOVAL, THE BALLOON WOULD NOT FULLY DEFLATE AND THERE WAS DIFFICULTY REMOVING THE DEVICE FROM THE GUIDE CATHETER. ALL INTERVENTIONAL EQUIPMENT WAS THEN REMOVED AS ONE UNIT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560102 ↗
• MalfunctionAug 11, 2023

  A 3.5MM BY 24 SYNERGY XD DRUG-ELUTING CORONARY STENT WAS DEPLOYED TO THE MID RIGHT CORONARY ARTERY. STENT FULLY DEPLOYED BUT THE BALLOON DID NOT FULLY DEFLATE. THE BALLOON COULD NOT BE PULLED BACK INTO THE GUIDE CATHETER. THE BALLOON AND GUIDE CATHETER SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY. NO HARM CAUSED TO THE PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, SYNERGY¿ XD (PER SITE REPORTER): THE LOCAL BOSTON SCIENTIFIC REPRESENTATIVE WAS NOTIFIED OF THIS EVENT. THEY ARE REPORTING THIS EVENT ON THEIR END AND HAS REQUESTED THE DEVICE AS SOON AS WE CAN RELEASE IT TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17508816 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, THE SHAFT BROKE ABOUT ONE-THIRD OF THE LENGTH BEHIND THE STENT WHEN ATTEMPTING TO CROSS THE LESION. THE DETACHED PORTION OF THE DEVICE WAS OUTSIDE OF THE BODY AT THE TIME OF THE FRACTURE, SO THE DEVICE WAS JUST PULLED AND REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121120 ↗
• InjuryMay 23, 2022Fracture; Fracture

  IT WAS REPORTED THAT STENT FRACTURE, CHEST PAIN, AND ST SEGMENT ELEVATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DIRECT STENTING. FOLLOWING STENT IMPLANTATION, POST DILATION WAS PERFORMED WITH A 3.5 NC EMERGE BALLOON CATHETER. A HAZY SPOT WAS SEEN WITHIN THE MID PORTION OF THE STENT AND IT WAS THOUGHT THAT THE STENT HAD FRACTURED. THE PATIENT STARTED HAVING CHEST PAIN AND ST ELEVATION, SO TWO NON-BOSTON SCIENTIFIC STENTS WERE PLACED IN THE HAZY AREA WHERE THE STENT WAS THOUGHT TO BE FRACTURED AND THE PROCEDURE WAS COMPLETED. THE PATIENT IMMEDIATELY STARTED RECOVERING. THE PATIENT WAS FULLY RECOVERED AND DISCHARGED THE NEXT DAY.

  Patient problems: Chest Pain; Non specific EKG/ECG Changes

  MAUDE report 14472832 ↗
• MalfunctionOct 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTICED THAT THE STENT WAS KINKED ONCE REMOVED FROM THE HOOP. THE PROCEDURE WAS COMPLETED WITH A NEW 3.50X24 SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12580755 ↗
• InjurySep 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE STENT WAS BEING PULLED BACK INTO A NON-BOSTON SCIENTIFIC (BSC) GUIDE EXTENSION CATHETER, THE STENT CAME OFF BALLOON AND WAS LEFT IN THE PROXIMAL PORTION OF RIGHT CORONARY ARTERY. MULTIPLE BALLOONS WERE INSERTED THROUGH THE STENT STARTING WITH A 1.5MM AND INCREASING IN SIZE. THE PHYSICIAN THEN DEPLOYED A NON-BSC STENT TO CRUSH THE DISLODGED STENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 12442680 ↗
• MalfunctionJul 19, 2021Failure to Advance; Difficult to Advance; Material Deformation; Failure to Advance; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN NON-TORTUOUS AND MODERATE TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. FOLLOWING PRE-DILATATION, A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND UPON INSPECTION OF THE STENT, IT APPEARED BUCKLED IN THE CENTER. THE ACTUAL MID STENT STRUT APPEARED LIKE IT WAS CAUGHT ON SOMETHING. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12187507 ↗
• MalfunctionJun 30, 2021Break; Failure to Advance; Break; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-JUN-2021. IT WAS REPORTED THAT A DEVICE HUB DETACHMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL CIRCUMFLEX. A 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. FURTHERMORE, DURING PROCEDURE WHILE THE PHYSICIAN WAS TRYING TO BEND THE SHAFT TO ADVANCE TO THE LESION. THE HUB THEN DETACHED FROM THE CATHETER. ANOTHER 3.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS USED BUT ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093814 ↗
• MalfunctionJun 1, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE PATIENT UNDERWENT LEFT HEART CATHETERIZATION (LHC). A 3.50 X 24MM SYNERGY XD DRUG ELUTING STENT WAS USED FOR TREATMENT. HOWEVER, THE BALLOON DELIVERY SYSTEM WAS STUCK AND WAS EVENTUALLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11913598 ↗