SYNERGY™ XD H7493941812400Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729981114), received between Mar 22, 2021 and May 7, 2026 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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.

• MalfunctionMay 7, 2026Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND CALCIFIED MID-LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PREDILATATION WITH A 3.5MM NON-COMPLIANT BALLOON, A 4.0 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ATTEMPTING TO CROSS THE LESION, THE SHAFT OF THE DEVICE BROKE. ALL EQUIPMENT WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112235 ↗
• MalfunctionNov 13, 2025Break; Nonstandard Device; Difficult to Advance; Break; Nonstandard Device; Difficult to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE LESS THAN 30% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL CORONARY ARTERY. A 4.00 X 12MM SYNERGY? XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE, AND UPON REMOVAL, THE SHAFT WAS FOUND TO BE BROKEN. THE DEVICE WAS RETRIEVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23546896 ↗
• InjuryJul 9, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT AN INFLATION ISSUE RESULTED IN A DISSECTION. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS INITIALLY DEPLOYED. HOWEVER, DURING INFLATION WITH THE ENCORE INDEFLATOR, THE PROXIMAL END OF THE BALLOON APPEARED TO INFLATE HIGHER THAN THE DISTAL EDGE, RESULTING IN A PROXIMAL EDGE DISSECTION. THE DISSECTION WAS NON-FLOW LIMITING AND GRADED AS TYPE A. SUBSEQUENTLY, A SECOND 4.00 X 20MM SYNERGY XD DES WAS DEPLOYED, BUT IT ALSO CONTRIBUTED TO ADDITIONAL DISSECTION IN THE DISTAL RCA. AN ADDITIONAL STENT WAS THEN PLACED TO COVER THE DISSECTED AREA AND COMPLETE THE PROCEDURE. THE PATIENT MADE A FULL RECOVERY, REMAINED STABLE, AND NO OTHER ISSUES WERE REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 22457957 ↗
• MalfunctionMay 28, 2024Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED CIRCUMFLEX ARTERY. A 4.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. THE BALLOON WAS INFLATED AT 12 ATMOSPHERES FOR 20-30 SECONDS, THE STENT WAS DEPLOYED BUT THE BALLOON WOULD NOT COME OUT. HOWEVER, THE BALLOON WAS DEFLATED BUT IT COULD NOT BE REMOVED AND WAS STUCK ON THE WIRE. SO PHYSICIAN HAD TO PULL OUT EVERYTHING. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19406684 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 4.00 X 12MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION THE SHAFT WAS SNAPPED WHILE PUSHING HARDER TO CROSS THE LESION AT THE ENTRANCE TO THE GUIDE CATHETER. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH A NON-BSC STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887772 ↗
• MalfunctionMar 6, 2023Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MILDLY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE SHAFT BROKE 18 INCHES (45.72 CM) FROM THE HUB OUTSIDE OF THE BODY. THE PROCEDURE WAS COMPLETED WITH A 4.0 X 16 SYNERGY DRUG-ELUTING STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16485362 ↗
• InjuryJan 20, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH PERIPHERAL VASCULAR DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS VESSEL BELOW THE KNEE. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT BROKE AND HAD TO BE SNARED. SUBSEQUENTLY, A 3.5 X 12 SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED. HOWEVER, UPON REMOVAL, THE SHAFT BROKE. THE DEVICE WAS REMOVED WITH NO PATIENT COMPLICATIONS. IT WAS FURTHER REPORTED THAT THERE WAS NO STENT DISLODGEMENT OCCURRED AND THE SECOND STENT WAS DEPLOYED SUCCESSFULLY. THE DEVICE RETRIEVED AND NO FRAGMENTS LEFT INSIDE PATIENT BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16216177 ↗
• MalfunctionDec 21, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE SHAFT BROKE. THE DEVICE WAS REPLACED, AND A NEW STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16022015 ↗
• InjuryNov 18, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS INSERTED AFTER PROPERLY PREPARING THE LESION WITH AN EMERGE BALLOON. HOWEVER, AFTER DEPLOYING THE STENT, THE BALLOON WAS DISCONNECTED FROM THE SHAFT AND NEEDED TO BE RETRIEVED. A SNARE WAS USED TO REMOVE THE FRACTURED DEVICE. AN ANGIOGRAM WAS PERFORMED TO ASSESS FOR ISSUES AND INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO CHECK THE STENT. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15826216 ↗
• MalfunctionOct 14, 2022Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29-SEP-2022. IT WAS REPORTED THAT SHAFT KINK OCCURRED. THE PATIENT PRESENTED WITH ANGINA. DURING PREPARATION, A 4.00 X 12MM SYNERGY XD STENT WAS USED FOR TREATMENT. HOWEVER, A KINK WAS NOTED AT 12 INCHES FROM THE HUB. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY XD STENT. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED ANALYSIS REVEALED HYPOTUBE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15606780 ↗
• MalfunctionJun 23, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO CROSS THE LESION AND IT WAS NOTICED THAT THE STENT STRUT WAS DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14788131 ↗
• MalfunctionJan 10, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT WHEN THE BALLOON WAS DEFLATED AND DURING WITHDRAWAL THE STENT DELIVERY SYSTEM COULD NOT BE PULL BACK INTO THE GUIDE GUIDE CATHETER. THE PHYSICIAN HAD TO PULL EVERYTHING OUT AND THE EVENT CAUSED DELAY OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204547 ↗
• MalfunctionNov 8, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION AND IT WAS NOTED THAT THE DEVICE WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12775336 ↗
• InjuryJun 7, 2021Break; Difficult to Remove; Material Rupture; Material Deformation; Break; Difficult to Remove; Material Rupture; Material Deformation

  IT WAS REPORTED THAT A BALLOON RUPTURE, SHAFT BREAK AND SURGERY OCCURRED. THE TARGET LESION HAD MODERATELY TO SEVERE TORTUOSITY. A 48MM SYNERGY XD BALLOON EXPANDABLE STENT WAS ADVANCED AND DEPLOYED THROUGH THE TORTUOUS LEFT ANTERIOR DESCENDING ARTERY BETWEEN TWO PREVIOUSLY PLACED STENTS. ANOTHER 12MM SYNERGY BALLOON EXPANDABLE STENT WAS ADVANCED WITHIN THE DISTAL LESION AND THE BALLOON WAS INFLATED TO 4ATM AND THE BALLOON RUPTURED. IT WAS NOTED THAT DURING ADVANCEMENT THE SHAFT OF THE DELIVERY SYSTEM MAY HAVE KINKED. DURING REMOVAL, THE 12MM SYNERGY BALLOON EXPANDABLE STENT BECAME CAUGHT AND THE SHAFT OF THE DELIVERY SYSTEM BROKE. THE PATIENT WAS SENT FOR SURGERY TO REMOVE THE DETACHED PORTION OF THE SHAFT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED VIA FACILITY MEDWATCH# (B)(4), THAT AFTER A LOSS OF PRESSURE DURING STENT DEPLOYMENT, THE STENT DID NOT DEPLOY. ON GENTLE RETRIEVAL, THE STENT SHAFT HAS BROKEN INTO THE LEFT ANTERIOR DESCENDING ARTERIAL SYSTEM.

  Patient problems: Foreign Body In Patient

  MAUDE report 11949533 ↗
• InjuryMar 23, 2021Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE AND INADEQUATE OR INSUFFICIENT APPOSITION OCCURRED. THE 99% STENOSED, TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND SEVERELY CALCIFIED OBUSE MARGINAL BRANCH SEGMENT/ LEFT CIRMUFLEX ARTERY. THE VESSEL WAS PREPARED WITH MULTIPLE BALLOONS AND A GUIDEZILLA GUIDE EXTENSION CATHETER WAS NEEDED TO FACILITATE BALLOON AND STENT DELIVERY. A 4.00X12MM SYNERGY XD DRUG-ELUTING STENT WAS DEPLOYED FOR TREATMENT. HOWEVER, DURING THE INITIAL INFLATION PRIOR TO REACHING NOMINAL PRESSURE THE BALLOON RUPTURED. IT WAS NOTED THAT THE BALLOON DID NOT EXPAND BEYOND THE EDGES. THE BALLOON WAS REMOVED BUT THE STENT WAS SEVERELY UNDEREXPANDED. AFTER MULTIPLE ATTEMPTS, 2.0 UP TO 4.0 BALLOONS WERE USED TO FULLY INFLATE THE STENT AND ENSURE ADEQUATE EXPANSION. THE PATIENT WAS TREATED SUCCESSFULLY WITH MULTIPLE STENTS BACK TO THE LEFT MAIN AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11558358 ↗
• MalfunctionMar 22, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.00 X 12MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT WHEN INFLATION WAS STARTED, THE SHAFT SNAPPED. IT WAS THOUGHT THE SHAFT MAY HAVE GOTTEN KINKED DURING HANDLING PRIOR TO THE STENT BEING INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS OKAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11547473 ↗