SYNERGY™ XD H7493941828220Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729980759), received between Jun 28, 2021 and Sep 25, 2026 — classified as 3 injuries, 8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Detachment of Device or Device Component; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902890 ↗
• MalfunctionAug 14, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED INTO THE PATIENT FOR TREATMENT; HOWEVER, THE PHYSICIAN COULD NOT LOCATE THE STENT ANYWHERE. IT WAS THEN FOUND OUT THAT THE STENT WAS STILL IN THE PROTECTIVE COVERING AND HAD BEEN REMOVED FROM THE STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983981 ↗
• InjuryMay 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT OCCLUSION OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 2.25 X 28MM AND 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENTS WERE DEPLOYED IN THE CIRCUMFLEX ARTERY AND POSTEROLATERAL DESCENDING ARTERY. THE PATIENT WAS WHEELED TO POST OPERATION AND COMPLAINED OF CHEST PAIN AND HAD ST-ELEVATION IN BOTH LATERAL AND INFERIOR LEADS. THE PATIENT WAS THEN BROUGHT BACK TO THE LABORATORY, RE-CATHETERIZED AND IT WAS OBSERVED THAT BOTH STENTS WERE NO LONGER PATENT. THE PATIENT ALSO EXPERIENCED A COMPLICATION OF MYOCARDIAL INFARCTION AND ISCHEMIA. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN STATES THAT HE DOES NOT BELIEVE THE PATIENT PROCESSES PLAVIX EFFICIENTLY AND WAS CHANGING TO BRILINTA. THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: Ischemia; Myocardial Infarction; Non specific EKG/ECG Changes; Obstruction/Occlusion

  MAUDE report 19264468 ↗
• MalfunctionOct 6, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INTRODUCTION, THE DEVICE BROKE MIDSHAFT OUTSIDE OF THE PATIENT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889708 ↗
• MalfunctionDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING A PROCEDURE INVOLVING A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT IT WAS NOTED THAT THE STENT HAD COME OFF FROM THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16015891 ↗
• MalfunctionDec 1, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.25 X 28MM SYNERGY XD DRUG ELUTING STENT WAS IMPLANTED FOR TREATMENT. DURING STENT IMPLANTATION, PROPER NOMINAL PRESSURE WAS USED ON THE STENT BALLOON TO DEPLOY WITH NO MORE THAN 20 SECONDS WAS USED TO INFLATE THE BALLOON. CONTRAST WAS USED IN A 50:50 SOLUTION WITH SALINE IN THE STENT BALLOON TO BE SEEN ANGIOGRAPHICALLY. THE DEVICE HELD PRESSURE DURING INFLATION WITH NO EVIDENCE OF A LEAK. THE BALLOON WAS PROPERLY EXPANDED WITH THE USE OF A NON-BOSTON SCIENTIFIC INDEFLATOR. COMPLETE BALLOON DEFLATION WAS VISUALIZED UNDER FLUOROSCOPY BEFORE REMOVING. HOWEVER, POST STENT IMPLANTATION, THE STENT BALLOON CATHETER WOULD NOT COME OUT OF THE BODY, OFF OF THE SAMURAI WIRE. THE PHYSICIAN REMOVED ALL WIRES AND DEVICES AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894114 ↗
• InjuryMay 31, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED CORONARY ARTERY. TWO SYNERGY XD DRUG-ELUTING STENTS, A 2.25 X 12MM AND A 2.25 X 28MM, WERE ADVANCED FOR TREATMENT. THE DEVICES HAD DIFFICULTY CROSSING THE LESION AND DISSECTION OCCURRED. THE PATIENT WAS FLOWN OUT FOR CORONARY ARTERY BYPASS GRAFT SURGERY.

  Patient problems: Vascular Dissection

  MAUDE report 14552232 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. THE 90% STENOSED TARGET LESION WAS AN AREA OF IN-STENT RESTENOSIS (ISR) OF A PREVIOUSLY IMPLANTED 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT LOCATED IN THE NON-CALCIFIED AND MILDLY TORTUOUS DIAGONAL BRANCH OF THE LEFT ANTERIOR DESCENDING ARTERY. ELUTING STENT. A 2.50MM X 20MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, DURING INITIAL INFLATION AT 12 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH STENT PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT DID WELL AND HAS BEEN DISCHARGED.

  Patient problems: Restenosis

  MAUDE report 12939896 ↗
• MalfunctionSep 15, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION EVEN AFTER MULTIPLE ATTEMPTS AND THE STENT WAS FOUND TO BE MANGLED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12477027 ↗
• MalfunctionSep 2, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHAFT BROKE DURING REMOVAL DUE TO TORTUOUS AND CALCIFIED VESSEL. 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 12419102 ↗
• MalfunctionJun 28, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED A 2.25 X 28MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, UPON REMOVING THE DEVICE FROM THE HOOP, THE DEVICE GOT FRACTURED 10 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12076671 ↗