SYNERGY™ XD H7493941820220Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729980735), received between Jan 13, 2021 and Sep 24, 2026 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Device-Device Incompatibility; Device Dislodged or Dislocated

  It was reported that stent dislodgement occurred.The patient presented with coronary artery disease and underwent percutaneous coronary intervention. The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery. During the procedure, a 7F guide catheter and a Guidezilla II guide extension catheter were used. After the lesion was pre-dilated with a 2.00mm Emerge balloon catheter, a 2.25 x 20mm SYNERGY? XD was advanced for treatment. During insertion, the stent got caught on the Guidezilla and started to dislodge from the delivery system. The physician removed the delivery system, and guide extension together, retrieving the dislodged stent with no stent left behind. The Guidezilla was reinserted, and a new stent was then introduced and successfully deployed. No patient complications were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50877502 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ANEURYSM OCCURRED. THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN (>= 72 HOURS) AND ANTIPLATELET MEDICATION OTHER THAN ASPIRIN (>= 72 HOURS). PRIOR TO THE PROCEDURE THE PATIENT RECEIVED HEPARIN, ANTITHROMBOTIC MEDICATION AND A LOADING DOSE OF 75 MG OF CLOPIDOGREL. THE 2.75 MM X 18 MM TARGET LESION LOCATED AT THE FIRST OBTUSE MARGINAL VESSEL WAS PRE-TREATED WITH FOUR DEVICES USING THE LARGEST BALLOON DIAMETER OF 2.25 MM X 20 MM WOLVERINE AND NON-COMPLIANT BALLOON ANGIOPLASTY CATHETER RESULTING IN 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE LESION WAS THEN SUCCESSFULLY TREATED WITH THE 2.25 MM X 20 MM SYNERGY XD STENT DEMONSTRATING 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. POST SYNERGY XD STENT PLACEMENT, ANEURYSM WITH TIMI FLOW 3 WAS INDICATED. THE PATIENT DISCHARGED.

  Patient problems: Aneurysm

  MAUDE report 25294494 ↗
• MalfunctionMay 8, 2026Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS SELECTED FOR TREATMENT. THE STENT WAS ATTEMPTED TO BE DELIVERED TO THE DISTAL CIRCUMFLEX ARTERY TWICE, AND ON THE THIRD ATTEMPT, THE DEVICE STRIPPED OFF THE BALLOON INSIDE THE HEMOSTATIC VALVE. THE DEVICE WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT MADE A FULL RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125535 ↗
• MalfunctionDec 9, 2025Difficult 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 THE RIGHT CORONARY ARTERY. AFTER A 5.5F NON-BOSTON SCIENTIFIC (BSC) GUIDE CATHETER WAS ENGAGED AND CORONARY GUIDEWIRES CROSSED THE LESION, A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TOWARD THE LESION AND BECAME STUCK IN THE GUIDE CATHETER. THE GUIDE CATHETER, THE NON-BSC GUIDE EXTENSION CATHETER, THE STENT, AND THE CORONARY GUIDEWIRES WERE ALL REMOVED TOGETHER FROM INSIDE THE GUIDE. AFTER REMOVAL, THE DEVICES WERE DISASSEMBLED FROM THE GUIDE, AND THE STENT FELL OFF ITS DELIVERY SYSTEM WITH THE STENT STILL INTACT AND UNDAMAGED. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759653 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ACUTE THROMBOSIS, ISCHEMIA, AND MYOCARDIAL INFARCTION OCCURRED. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS IMPLANTED IN A CORONARY ARTERY. UPON CLOSURE OF THE ACCESS POINT (RADIAL ARTERY), OCCLUSION OF THE IMPLANTED STENT OCCURRED (ACUTE STENT THROMBOSIS). ANOTHER STENT WAS IMPLANTED TO TREAT THE OCCLUSION AND THE PROCEDURE WAS COMPLETED. THE PATIENT EXPERIENCED ISCHEMIA AND MYOCARDIAL INFARCTION BUT FULLY RECOVERED.

  Patient problems: Ischemia; Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 18975834 ↗
• MalfunctionJul 25, 2023Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT A DEVICE PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY. WHEN THE STENT WAS REMOVED, THE DELIVERY SHAFT APPEARED TO HAVE A PINHOLE IN THE DISTAL THIRD OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 80% STENOSED AND MILDLY TORTUOUS WITH MILD ANGULATION. IT IS UNKNOWN IF THE PINHOLE WAS PRESENT UPON REMOVAL FROM THE PACKAGING. THE PINHOLE WAS DISCOVERED AFTER THE STENT WAS REMOVED BECAUSE IT WOULD NOT DEPLOY DURING INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393581 ↗
• InjuryMar 10, 2023Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED AND THE PATIENT EXPERIENCED ARRHYTHMIA. THE 100% OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED OBTUSE MARGINAL BRANCH. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE STENT WAS DEPLOYED, HOWEVER, UPON PULLING NEGATIVE, THE BALLOON APPEARED TO BE STUCK ON THE STENT. THE BALLOON WAS REINFLATED AT LOW ATMOSPHERES AND DEFLATED SLOWLY WALKING DOWN THE PRESSURE. THE BALLOON REMAINED STUCK TO THE STENT EVEN AFTER MULTIPLE NEGATIVES PULLED ON STENT DELIVERY SYSTEM (SDS). THE PHYSICIAN ALSO ATTEMPTED TO PUSH BALLOON FORWARD AND BACKWARD, HOWEVER, THE BALLOON REMAINED STUCK. A BUDDY WIRE WAS ADVANCED TO SDS, BUT STILL THERE WAS NO CHANGE. SUBSEQUENTLY, A GUIDE ADVANCED OVER THE SYSTEM TO LOCATION OF STUCK STENT BALLOON, BALLOON THEN PULLED BACK AND INTO GUIDE AND REMOVED INTACT. PATIENT THEN BECAME UNSTABLE. REPEAT BALLOON INFLATIONS WITH A NEW BALLOON TO STENT WERE PERFORMED. MANY ATTEMPTS TO REMOVE THE STENT BALLOON POSSIBLY LED TO THROMBOSIS AND THE PATIENT EXPERIENCED ARRHYTHMIA. IN THE PHYSICIAN'S OPINION, THE DEVICE OR PROCEDURE CONTRIBUTED TO PATIENT COMPLICATIONS WHICH LED FOR R

  Patient problems: Arrhythmia

  MAUDE report 16526461 ↗
• MalfunctionOct 12, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE, HOWEVER: IT WAS NOTED THAT THE SHAFT OF THE DEVICE BROKE IN THE GUIDE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15590547 ↗
• MalfunctionOct 7, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS FOUND THAT THE GUIDEWIRE EXITED THE STENT DELIVERY SYSTEM AT A LOCATION OTHER THAN THE MONORAIL EXIT PORT BUT CLOSE TO THE MONORAIL EXIT PORT WHEREIN THE FRACTURE OF THE DEVICE WAS LOCATED. THE DEVICE WAS REMOVED INTACT AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15563712 ↗
• InjuryJan 31, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED. DURING AN ATTEMPT TO IMPLANT A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT, THE STENT DISLODGED FROM THE BALLOON AND EMBOLIZED. ADDITIONAL INTERVENTION WAS REQUIRED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13401032 ↗
• MalfunctionNov 7, 2021Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 100% OCCLUDED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL DIAGONAL ARTERY. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ATTEMPTED TO PULL NEGATIVE ON BALLOON, THE BLOOD GOES BACK IN AND FOUND THE BALLOON WAS BURST AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12757793 ↗
• MalfunctionJul 30, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DIAGONAL ARTERY. A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND ONE OF THE STRUTS ON THE DISTAL END OF THE STENT WAS FOUND TO BE BENT. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12256109 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.25 X 20MM SYNERGY XD DRUG ELUTING STENT WAS LOADED ONTO THE WIRE; HOWEVER, THE SHAFT BROKE IN HALF BEFORE ENTERING THE PATIENT'S BODY. 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 11829446 ↗
• MalfunctionJan 13, 2021Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY WAS ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. AFTER PRE-DILATION, A 2.25 X 20MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. THE DEVICE WAS INFLATED AND THE STENT WAS EXPANDED AT 11 ATMOSPHERES. WHEN THE STENT WAS EXPANDED, THE INDEFLATOR WAS RELEASED TO DEFLATE THE BALLOON. HOWEVER, IT WAS NOTICED THAT THE BALLOON DID NOT DEFLATE. SEVERAL ATTEMPTS WERE MADE TO REINFLATE AND DEFLATE THE BALLOON AS TO TRY TO RELEASE THE BALLOON FROM THE STENT. THE DOCTOR ROTATED AND PULLED THE CATHETER IN AN ATTEMPT TO DISLODGE THE BALLOON FROM THE STENT WITH SUCCESS. NO PATIENT COMPLICATIONS WERE REPORTED.

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

  MAUDE report 11163720 ↗