SYNERGY™ XD H7493941816220Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729980728), received between Jan 11, 2021 and May 13, 2026 — classified as 4 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED. THE 12 MM X 2.25 MM TARGET LESION WAS LOCATED IN THE RAMUS INTERMEDIUS (RI). THE TARGET LESION WAS PRE-TREATED WITH A 2.00 MM X 12 MM NON-COMPLIANT BALLOON ANGIOPLASTY CATHETER RESULTING IN 30% STENOSIS WITH TIMI FLOW 3. FOLLOWING PREDILATION, A 2.25 MM X 16 MM SYNERGY XD DRUG ELUTING STENT WAS DEPLOYED AT 14 ATM FOR 20 SECONDS. POST-DEPLOYMENT, A TYPE C STENT EDGE DISSECTION WAS OBSERVED. THE DISSECTION WAS SUCCESSFULLY TREATED WITH A 2.25 X 8MM NON-BOSTON SCIENTIFIC DRUG ELUTING STENT. THE PATIENT WAS DISCHARGED THE SAME DAY.

  Patient problems: Vascular Dissection

  MAUDE report 25160542 ↗
• InjuryMar 4, 2026Fracture; Difficult to Advance

  IT WAS REPORTED THAT DETACHMENT OCCURRED. THE 2.25 X 16MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR TREATMENT OF THE TARGET LESION LOCATED IN A MILDLY TORTUOUS VESSEL. THE DEVICE WAS ADVANCED AND REMOVED WITHOUT COMPLICATION OR DAMAGE. FOLLOWING ADDITIONAL PRE-DILATION, THE STENT WAS RE-ADVANCED. IT BECAME APPARENT THAT FURTHER PRE-DILATION WAS REQUIRED. DURING REMOVAL OF THE STENT, APPROXIMATELY ONE-QUARTER OF THE STENT SHEARED OFF. THE REMAINING THREE-QUARTERS OF THE STENT, STILL ON THE BALLOON, WAS REMOVED INTACT. THE SHEARED OFF PORTION OF THE STENT REMAINED IN THE VESSEL AND WAS SUCCESSFULLY DILATED USING A BALLOON ADVANCED OVER THE EXITING WIRE. THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 24509112 ↗
• MalfunctionMay 28, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE STERILITY WAS COMPROMISED. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. DURING THE PREPARATION, THE PACKAGE INSIDE THE BOX WAS ALREADY PARTIALLY OPENED, COMPROMISING THE STERILITY OF THE COMPLAINT DEVICES DUE TO A VISIBLE TEAR OR HOLE IN THE INNER PACKAGES AND THE INNER POUCH NOT BEING INTACT. THE PROCEDURE WAS COMPLETED ANOTHER 2.25X16MM SYNERGY XD DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19408878 ↗
• 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 19264466 ↗
• MalfunctionNov 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON THE BALLOON. A 2.25 X 16MM SYNERGY XD STENT BALLOON WAS SELECTED FOR TREATMENT. DURING PREPARATION OF THE DEVICE THE STENT DISLODGED AND WAS NOT PROPERLY MOUNTED ON THE BALLOON. THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18108160 ↗
• MalfunctionSep 5, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A SHAFT HOLE OCCURRED. A 2.25 X 16MM SYNERGY DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT A CONTRAST WAS LEAKING FROM THE MIDSHAFT WHICH WOULD NOT ALLOW THE STENT TO BE PREPPED APPROPRIATELY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685706 ↗
• MalfunctionDec 16, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08-DEC-2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. FOLLOWING PRE-DILATATION WITH A WOLVERINE BALLOON, A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED INTO A VERY CALCIFIED LESION BUT FAILED TO CROSS. THE PROCEDURE WAS NOT COMPLETED DUE TO AN UNSPECIFIED REASON. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SHAFT BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997135 ↗
• InjuryDec 1, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 2.25X16 SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE FAILED TO CROSS THE LESION THAT RESULTED IN DISSECTION OF VESSEL WITHOUT SYMPTOMS OR LOSS OF FLOW. THE PATIENT WAS THEN ADMITTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 15896639 ↗
• MalfunctionNov 24, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INSERTION, THE DELIVERY DEVICE BROKE IN HALF, AND IT WAS 2 FEET UP FROM THE HUB. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15863740 ↗
• MalfunctionSep 30, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 98% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED MID OBTUSE MARGINAL ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. DURING THE PROCEDURE AS THE STENT WAS BEING FORCE TO CROSS THE LESION, THE MID SHAFT WAS BROKE IN HALF. A GUIDEZILLA CATHETER AND A TELESCOPE WERE USED TO ASSIST THE STENT TO CROSS THE LESION BUT THE ATTEMPT WAS NOT SUCCESSFUL. THE DEVICE WAS REMOVED INTACT BY PULLING IT OUT. THE PROCEDURE WAS PERFORMED WITH ANGIOPLASTY AND WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15509110 ↗
• MalfunctionSep 13, 2022Material Rupture; Failure to Advance; Material Rupture; Failure to Advance

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE THE BALLOON BURST OUT AND FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411670 ↗
• MalfunctionJun 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN OBJECT WAS OBSERVED ON THE STERILE UNIT. A FOREIGN OBJECT WAS NOTED ON THE 2.25 X 16MM SYNERGY XD STENT PRIOR TO BEING INTRODUCED INTO THE PATIENT. THE DEVICE WAS NOT USED IN THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14829053 ↗
• MalfunctionJun 13, 2022Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE. THE 70% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION, A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING ADVANCING AND THE STENT WAS FRAYED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME SIZE STENT 2.25 X 16. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14672907 ↗
• MalfunctionJun 6, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE PROXIMAL SHAFT BROKE OUTSIDE OF THE BODY. THE DEVICE WAS COMPLETELY REMOVED AND NOTHING WAS LEFT IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14603206 ↗
• MalfunctionMay 17, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD). THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND WAS INFLATED AT 8 ATMOSPHERES. HOWEVER, WHEN THEY CAME DOWN WITH THE BALLOON AND PULLED BACK THE SHAFT, THE STENT DETACHED FROM THE BALLOON POST INFLATION. THE STENT MOVED UP THE LAD AND WAS LEFT IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14417150 ↗
• MalfunctionApr 19, 2022Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION. THE PHYSICIAN REINSERTED THE STENT DELIVERY SYSTEM BUT THE SHAFT BROKE 22CM FROM THE HUB OUTSIDE THE PATIENT'S BODY. 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 14149007 ↗
• MalfunctionMar 17, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09-MAR-2022. IT WAS REPORTED THAT CROSSING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A TORTUOUS AND COMPLEX VESSEL. A 2.25 X 16MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13792489 ↗
• MalfunctionFeb 7, 2022Inflation Problem; Inflation Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JAN2022. IT WAS REPORTED THAT THE BALLOON INFLATION FAILURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED DIAGONAL BRANCH. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION, THE BALLOON WOULD NOT INFLATE. THE STENT WAS REMOVED AND THE IT WAS NOTICED THAT THERE WAS BLOOD IN THE INFLATOR. THE PROCEDURE WAS COMPLETED WITH A 2.25X12MM SYNERGY XD DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A PARTIAL FRACTURE OF THE SHAFT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471995 ↗
• MalfunctionJan 5, 2022Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, THE DEVICE ENCOUNTERED DIFFICULTIES IN ADVANCING TO THE LESION. THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168371 ↗
• MalfunctionNov 22, 2021Inflation Problem; Leak/Splash; Difficult to Advance; Inflation Problem; Leak/Splash; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15NOV2021. IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON WOULD NOT INFLATE PROPERLY AND HOLD PRESSURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A HYPOTUBE SEPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857813 ↗
• MalfunctionJan 12, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 80-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE TRYING TO CROSS THE LESION, THE SHAFT BROKE OUTSIDE THE PATIENT 20-25CM DISTAL FROM THE HUB. THE DEVICE WAS COMPLETELY PULLED OUT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11154840 ↗
• MalfunctionJan 11, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. A 2.25 X 16MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. THERE WAS NO INDICATION OF DAMAGE UPON REMOVING THE DEVICE FROM THE PACKAGE AND WHEN REMOVED FROM THE PLASTIC HOOP. HOWEVER, WHEN THE PHYSICIAN REMOVED THE STYLET, THE STENT CAME OFF THE BALLOON AND WAS STUCK HALF WAY IN AND HALF WAY OUT AT THE PROXIMAL END OF THE STENT PROTECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. IT WAS FURTHER REPORTED THAT THEY ENCOUNTERED DIFFICULTY IN REMOVING THE STENT PROTECTOR AND THE PRODUCT MANDREL. THE STENT WAS STUCK IN THE DISTAL END OF PROTECTOR WHEN IT COMPLETELY SEPARATED FROM THE BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11149292 ↗