SYNERGY™ XD H7493941838270Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729980933), received between Mar 12, 2021 and Sep 25, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Difficult to Remove; Failure to Deflate

  It was reported that deflation failure occurred resulting in patient complications and additional intervention.The left anterior descending (LAD) coronary artery was noted to provide two diagonal branches and terminated as the apical recurrent branch. The proximal LAD was noted to have diffuse long 50 to 60% disease with 80 to 90% mid disease. Following atherectomy of the LAD, direct stenting was performed with a 2.75 x 38 mm Synergy XD drug eluting stent. The stent delivery system (SDS) balloon was inflated for 10-15 seconds during stent implantation and post implant, was deflated for 20 seconds before attempting to pull back the device. The proximal segment remained inflated, however, and only the distal portion of the balloon was deflated. The SDS was stuck in the patient for approximately 20 minutes and during that time, the patient reported chest pain and ST elevations were noted. Multiple attempts were made to puncture the inflated balloon with different wires and micro catheters, but all failed. A 3-way stop cock was then connected and the technician continued to draw negative until the balloon deflated and was removed. The open-heart team had been called to perform further

  Patient problems: Chest Pain; Non specific EKG/ECG Changes

  MAUDE report 50893097 ↗
• InjuryOct 1, 2025Break; Material Rupture; Failure to Advance; Detachment of Device or Device Component; Activation Failure; Break; Material Rupture; Failure to Advance; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT A DEVICE ISSUE OCCURRED RESULTING IN PATIENT COMPLICATIONS. THE AT LEAST 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED MID-RIGHT CORONARY ARTERY. A 2.75 X 38 MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS ADVANCED BUT FAILED TO CROSS THE LESION. A NON-BOSTON SCIENTIFIC GUIDE EXTENSION WAS THEN USED TO DELIVER THE STENT. HOWEVER, DURING INITIAL INFLATION, THE STENT DELIVERY SYSTEM (SDS) BALLOON RUPTURED BEFORE REACHING THE NOMINAL PRESSURE OF 11 ATMOSPHERES. WHEN THE SDS WAS REMOVED, IT WAS NOTED THAT THE HYPTUBE WAS BROKEN AND THE BALLOON, WHICH WAS BROKE OFF THE HYPOTUBE, HAD BEEN LEFT BEHIND INSIDE THE PARTIALLY EXPANDED STENT. THE PATIENT EXPERIENCED URINARY RETENTION AND THE VESSEL WAS OCCLUDED. THE BALLOON COULD NOT BE SNARED, SO A SECOND STENT WAS DEPLOYED, CRUSHING THE BALLOON INSIDE THE FIRST STENT. THE PATIENT WAS MONITORED BECAUSE THE DISTAL PART OF THE STENT COULD NOT BE FULLY EXPANDED. THE PATIENT FULLY RECOVERED. IT WAS FURTHER REPORTED THAT PREVIOUSLY A URINARY RETENTION OCCURRED. HOWEVER, IT IS NOW REPORTED THAT THERE WAS NO ISSUE. IT WAS FURTHER REPORTED VIA MEDWATCH MW5176349 THAT THE TIP WAS FRACTURED LEAVI

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Urinary Retention

  MAUDE report 23197079 ↗
• MalfunctionOct 30, 2024Break; Difficult to Remove; Activation Failure; Break; Difficult to Remove; Activation Failure

  IT WAS REPORTED VIA (B)(4) THAT INADEQUATE APPOSITION AND REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE OBTUSE MARGINAL. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT WITH A BALLOON. THE STENT DID NOT FULLY EXPAND IN THE MIDDLE AND WHEN THE STENT BALLOON WAS DEFLATED AND RETRACTED INTO THE GUIDE CATHETER, IT WOULD NOT MOVE. AN ATTEMPT TO DEFLATE THE STENT BALLOON WAS MADE, HOWEVER THE DEVICE REMAINED STUCK. THE DEVICE WAS PULLED AND THE ATTEMPT UNSHEATHED A LARGE PORTION OF THE SHAFT TO THE DEVICE LEAVING BOTH THE STENT BALLOON AND THE DEVICE SHAFT IN THE VESSEL HANGING INTO THE AORTA. AN ATTEMPT WAS MADE TO RE-WIRE THE VESSEL AND USE OTHER BALLOONS OR SNARING DEVICES TO FREE THE BALLOON AND SHAFT, HOWEVER WAS UNSUCCESSFUL. TO CONCLUDE, A STENT WAS PLACED DOWN THE LEFT MAIN INTO THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY AND ANOTHER STENT DOWN THE CIRCUMFLEX TO PROTECT THE MAIN VESSELS. IT WAS FURTHER REPORTED THAT NOT ALL PARTS WAS RECOVERED. THE TIP OF THE CATHETER INCLUDING THE BALLOON PORTION WAS NOT RECOVERED. THE PATIENT WAS STABLE AND WAS DISCHARGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20568108 ↗
• InjuryOct 21, 2024Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL FIRST OBTUSE MARGINAL (OM). A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT AND DEPLOYED WITH NO ISSUES. HOWEVER, WHEN THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS FULLY DEFLATED, IT REMAINED STUCK IN THE STENT. MULTIPLE PULLS AND MULTIPLE INFLATIONS AND DEFLATIONS ENSUED WITHOUT SUCCESS, AND A FAILED ATTEMPT WAS MADE TO TRY AND GET A SECOND WIRE PAST THE STENT. A HARD PULL WAS MADE TO THE SDS CATHETER AT WHICH TIME THE SHAFT BROKE. THE PROXIMAL HALF WAS RETRIEVED, BUT THE DISTAL HALF REMAINED STUCK IN THE STENT. THE CATHETER TIP EMBOLIZED IN THE VESSEL AND THE DOCTOR OPTED TO JAIL THE TIP INTO THE OM WITH ANOTHER STENT, EFFECTIVELY SHUTTING DOWN THE OM. THE BALLOON BEING STUCK AND THE FORCED NEEDED TO REMOVE IT CAUSED A NON-FLOW LIMITING DISSECTION IN THE OSTIUM OF THE OM. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND STANDARD OF CARE AND TREATED WITH HEAVY ANTICOAGULATION AND OBSERVATION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND LATER DISCHARGED.

  Patient problems: Embolism/Embolus; Foreign Body In Patient; Reduced Blood Flow; Vascular Dissection

  MAUDE report 20499920 ↗
• MalfunctionAug 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING PREPARATION, THE STENT WAS DETACHED FROM THE BALLOON AND WAS PULLED OFF FROM THE BALLOON DELIVERY SYSTEM WHEN THE STYLET AND PROTECTIVE COVERING WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19990717 ↗
• MalfunctionApr 19, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS CORONARY ARTERY. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE HYPOTUBE BROKE AT 20CM FROM THE BALLOON HUB. THE DETACHED PORTION OF THE DEVICE WAS PULLED OUT OVER THE WIRE, AND NOTHING WAS LEFT BEHIND. THE PROCEDURE WAS COMPLETED WITH ALTERNATE 2.75 X 38 STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19145367 ↗
• MalfunctionMar 25, 2024Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE ENTRAPMENT OF THE DEVICE OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC GUIDEWIRE PRESSURE TO THE LESION. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT WAS STUCK INTO THE GUIDEWIRE AND COULD NOT BE ADVANCED NOR REMOVED. AS IT WAS TRIED TO REMOVED FROM THE WIRE, THE STENT WAS DEFORMED. BOTH DEVICES WERE REMOVED AS ONE UNIT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18969369 ↗
• MalfunctionApr 20, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUES OCCURRED AND CATHETER REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN A CORONARY VESSEL. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. DURING DEPLOYMENT, THE PHYSICIAN FELT LIKE THE BALLOON WAS STICKING TO THE STENT AND DEFLATION TOOK 30 SECONDS. DURING REMOVAL OF THE STENT DELIVERY SYSTEM, RESISTANCE WAS FELT. THE BALLOON WAS EVENTUALLY REMOVED IN A FULLY DEFLATED STATE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16781024 ↗
• MalfunctionMar 12, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 2.75 X 38MM SYNERGY XD DRUG-ELUTING STENT WAS INTRODUCED DURING A PROCEDURE, BUT FELT STICKY AND FAILED TO RACK OVER THE WIRE WITHIN THE GUIDE CATHETER. THE DEVICE WAS REMOVED ALONG WITH THE WIRE. A KINK WAS NOTED IN THE MID PROXIMAL SECTION AND THE DISTAL END LOOKED BROKEN AND FRAYED. THE WIRE WAS WIPED DOWN AND THE PROCEDURE COMPLETED WITH ANOTHER STENT. THERE WERE NO PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11476355 ↗