SYNERGY™ XD H7493941848400Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 08714729985242), received between Sep 3, 2020 and Sep 28, 2026 — classified as 6 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Device Dislodged or Dislocated; Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922594 ↗
• MalfunctionFeb 9, 2026Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT MOVE ON BALLOON OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR USE. HOWEVER, WHEN THE PACKAGE WAS OPENED AND REMOVED THE DEVICE FROM THE HOOP, THE STENT WAS ALREADY ACCORDIONED OFF OF THE BALLOON. A NEW 4.00 X 48MM SYNERGY XD DES WAS THEN USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292083 ↗
• MalfunctionFeb 5, 2026Fracture

  IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. A 4.00 X 48MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, AS THE STENT WAS BEING INSERTED INTO THE PATIENT'S BODY, IT WAS PERCEIVED THAT IT WAS FRACTURING. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269692 ↗
• MalfunctionDec 29, 2025Break; Nonstandard Device; Deformation Due to Compressive Stress; Break; Nonstandard Device; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT A FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHILE ADVANCING OVER THE WIRE, THE PROXIMAL PORTION OF THE DEVICE KINKED AND THE CATHETER BROKE. THE PROCEDURE WAS COMPLETED ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23918962 ↗
• MalfunctionNov 25, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY TO SEVERELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DEPLOYMENT. HOWEVER, DURING INITIAL INFLATION AT 4 ATMOSPHERES FOR 1-2 SECONDS, THE STENT BALLOON RUPTURED. THE DEVICE WAS REMOVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644975 ↗
• MalfunctionJul 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, PRIOR TO THE PROCEDURE, THE STENT CAME OUT FROM THE BALLOON WHILE BEING REMOVED FROM THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22379445 ↗
• MalfunctionApr 23, 2025Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. IT WAS NOTED THAT THE SHAFT BROKE INSIDE THE PATIENT'S BODY AND WAS NOT LEFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21893832 ↗
• MalfunctionApr 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USED; HOWEVER, THE STENT WAS NOT SEATED PROPERLY AND WAS NOT USED INTO THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21883313 ↗
• MalfunctionJan 31, 2025Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED CORONARY ARTERY. PRE-DILATATION WAS PERFORMED WITH A 4.0MM EMERGE BALLOON CATHETER. A 4.00X48MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT, BUT IT WOULD NOT ADVANCE THROUGH THE GUIDE EXTENSION CATHETER. WHEN THE STENT WAS PULLED OUT, IT BECAME STRETCHED OVER THE END OF THE DISTAL PORTION OF THE BALLOON AND WAS DISLODGED FROM THE DELIVERY SYSTEM. SUBSEQUENTLY, ANOTHER 4.00X48MM SYNERGY XD DES WAS SELECTED FOR TREATMENT, BUT THE BALLOON AND STENT BECAME MALFORMED, AND THE STENT WAS AGAIN DISLODGED FROM THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21287355 ↗
• MalfunctionNov 19, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. WHILE ADVANCING A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT THROUGH A 6F GUIDEZILLA GUIDE EXTENSION CATHETER, THE STENT CAME OFF OF THE BALLOON. THE GUIDEZILLA WAS THEN REMOVED, AND THE STENT CAME OUT WITH IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20719511 ↗
• MalfunctionNov 19, 2024Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT WAS STRIPPED OFF. A 4.00 X 48MM SYNERGY AND GUIDEZILLA II WERE SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS ADVANCED THROUGH THE GUIDEZILLA, HOWEVER, THE STENT WAS STRIPPED OFF. THE GUIDEZILLA AND STENT WERE REMOVED TOGETHER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20719042 ↗
• InjuryOct 14, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION, WHICH WAS 85% STENOSED, WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED LEFT MAIN ARTERY. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR DILATATION. HOWEVER, DURING THE REMOVAL OF THE DEVICE AFTER STENT DEPLOYMENT, THE SHAFT BROKE. AN ADDITIONAL GUIDEWIRE WAS PLACED, AND A BALLOON WAS UTILIZED TO PIN THE BROKEN DEVICE, SUCCESSFULLY EXTRACTING EVERYTHING FROM THE BODY. THE PROCEDURE WAS THEN COMPLETED USING AN ALTERNATE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441096 ↗
• MalfunctionAug 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. DURING PREPARATION, UPON REMOVAL FROM THE HOOP, IT WAS NOTICED THAT THE STENT MESH WAS HALFWAY OFF THE BALLOON. THE DEVICE WAS PUT ASIDE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20018758 ↗
• MalfunctionJul 22, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT STENT DIFFICULTY REMOVAL FROM THE STENT OCCURRED. DURING THE PROCEDURE, A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS PREPPED AND ADVANCED TO TREAT THE LESION. IT WAS DEPLOYED, AND THE SDS WAS DEFLATED. THE STENT BALLOON WAS THEN REINFLATED FOR POST-DILATION. HOWEVER, UPON DEFLATION, THE BALLOON APPEARED STUCK TO THE STENT AND WOULD NOT RETRACT. MULTIPLE ATTEMPTS TO PULL THE BALLOON WERE MADE. EVENTUALLY, THE BALLOON WAS RELEASED FROM THE STENT AND REMOVED FROM THE BODY INTACT. THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19798834 ↗
• MalfunctionJun 21, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT DISLODGED OUTSIDE THE PATIENT. DURING PREPARATION, A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON OPENING THE PACKAGE, THE STENT CAME OFF THE BALLOON AND WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITHOUT ANY PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19588272 ↗
• MalfunctionMay 3, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. UPON REMOVING THE STENT FROM THE PACKAGING HOOP, IT WAS NOTED THAT THE STENT WAS DEFORMED AND ALMOST CAME OFF OF THE STENT BALLOON. THE STENT WAS NOT USED, AND A NEW 4.0X48 SYNERGY DRUG-ELUTING STENT WAS DEPLOYED SUCCESSFULLY WITH NO ISSUES. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244178 ↗
• MalfunctionJan 4, 2024Deflation Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Deflate; Deflation Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Failure to Deflate

  IT WAS REPORTED THAT THE BALLOON DID NOT FULLY DEFLATE. THE PATIENT PRESENTED EXPERIENCING A ST-ELEVATION MYOCARDIAL INFARCTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 4.00 X 48 MM SYNERGY XD STENT WAS SUCCESSFULLY DEPLOYED. THE DELIVERY SYSTEM BALLOON WAS THEN INFLATED AT 15 ATM. AFTER MANY ATTEMPTS TO PULL NEGATIVE PRESSURE FOR SEVERAL SECONDS, THE BALLOON FAILED TO FULLY DEFLATE AND COULD NOT BE RETRACTED THROUGH THE GUIDE CATHETER. THE GUIDE CATHETER, GUIDEWIRE AND PARTIALLY INFLATED BALLOON WERE PULLED AND REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18445052 ↗
• MalfunctionDec 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, A DEVICE COMPONENT WAS DETACHED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352257 ↗
• MalfunctionDec 12, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT MATERIAL SEPARATION OCCURRED. A 4.00 X 48MM SYNERGY DRUG-ELUTING STENT WAS SELECTED FOR USE DURING THE PROCEDURE. HOWEVER, IT WAS NOTED THAT MATERIAL SEPARATION HAD OCCURRED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18311473 ↗
• MalfunctionNov 27, 2023Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OUTSIDE THE PATIENT OCCURRED. A 4.00 X 48MM SYNERGY XD STENT WAS SELECTED FOR USE. WHEN REMOVING THE STENT PROTECTOR, THE STENT STUCK AND WAS STRETCHED OUT, COMING OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209892 ↗
• MalfunctionNov 9, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE BALLOON BURST WITHIN A STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18100282 ↗
• MalfunctionOct 23, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE AND DETACHMENT OCCURRED. UPON OPENING THE DEVICE PACKAGING, A 4.00 X 48 MM SYNERGY XD WAS NOTED TO BE "OFF THE BALLOON AND STRETCHED OUT." THERE WAS NO DAMAGE TO THE PACKAGING NOTICED. THERE WAS NO REPORTED HARM AS THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17987880 ↗
• InjuryOct 20, 2023Break; Premature Activation; Difficult to Remove; Break; Premature Activation; Difficult to Remove

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT AND DIFFICULTY IN REMOVAL OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). ATHERECTOMY AND CUTTING BALLOONS WERE USED SUCCESSFULLY WITHOUT ANY COMPLICATIONS. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON DELIVERY, THE OPERATOR BENT THE PROXIMAL END OF THE DELIVERY HYPOTUBE WHILE ATTEMPTING TO COMPLETE CROSSING THE STENT. THE OPERATOR REMOVED THE DEVICE BECAUSE OF THE INABILITY TO INFLATE THE DELIVERY SYSTEM. UPON REMOVAL, AIR WAS SUCKED INTO THE BALLOON BECAUSE OF THE CHANGE IN PRESSURE, WHICH IN TURN, PARTIALLY INFLATED THE DEVICE, ADDING TO THE INABILITY TO REMOVE IT. IT WAS NOTED THE PROXIMAL END OF THE DELIVERY SYSTEM BROKE AT THE BENT AREA OUTSIDE THE GUIDE CATHETER, LEAVING THE STENT AND BALLOON INSIDE OF THE STENT, PARTIALLY STUCK IN THE OSTIUM OF THE RCA AND IN THE AORTA. ALL SYSTEMS AND WIRES WERE SUCCESSFULLY REMOVED VIA SNARE THROUGH THE ARTERIOTOMY ACCESS SITE. THE PROCEDURE WAS COMPLETED WITH A 2 4.0MM SYNERGY XD AND THE PATIENT WAS KEPT OVERNIGHT FOR EVALUATION AND WAS DISCHA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17980754 ↗
• MalfunctionSep 25, 2023Defective Device; Adverse Event Without Identified Device or Use Problem; Defective Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30-AUG-2022. IT WAS REPORTED THAT DEVICE DAMAGE OCCURRED. A 4.00 X 48MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT, BUT THE DEVICE WAS NOTED TO BE DAMAGED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17811044 ↗
• MalfunctionApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.00 X 48MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED FOR USE. HOWEVER, WHEN REMOVING THE STENT OUT OF THE HOOP, THE STENT APPEARED TO BE OFF THE BALLOON. THE DEVICE WAS NOT INSERTED INTO THE BODY. THE PROCEDURE WAS COMPLETED WITH A NEW 48MM SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16724097 ↗