SYNERGY™ XD H7493941824450Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729981213), received between Jun 14, 2021 and Nov 24, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Nonstandard Device; Material Rupture; Nonstandard Device; Material Rupture

  IT WAS REPORTED THAT BALLOON PINHOLE OCCURRED. THE TARGET LESION WAS LOCATED IN A CORONARY ARTERY. A 4.50 X 24 MM SYNERGY? XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. PRIOR TO INFLATION OF THE STENT DELIVERY BALLOON, THE TECHNICIAN PULLED NEGATIVE ON THE NON-BOSTON SCIENTIFIC INFLATION DEVICE AND OBSERVED BLOOD FILLING THE DEVICE. THE STENT SYSTEM WAS REMOVED, AND PINHOLE WAS OBSERVED IN THE BALLOON MATERIAL. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23636637 ↗
• MalfunctionNov 4, 2025Entrapment of Device; Nonstandard Device; Difficult to Remove; Failure to Deflate; Entrapment of Device; Nonstandard Device; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT BALLOON DEFLATION ISSUE AND REMOVAL DIFFICULTIES OCCURRED. THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE AND UNDERWENT A PERCUTANEOUS CORONARY INTERVENTION. THE TARGET LESIONS WERE LOCATED IN THE CIRCUMFLEX (CX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERIES. A 3.50 X 32 MM SYNERGY MEGATRON? DRUG-ELUTING STENT (DES) WAS DEPLOYED IN THE CX ARTERY. FOLLOWING DEPLOYMENT, THE BALLOON FAILED TO DEFLATE AND WAS DIFFICULT TO REMOVE. THE PHYSICIAN ATTEMPTED TO APPLY ADDITIONAL NEGATIVE PRESSURE, BUT THIS WAS UNSUCCESSFUL. THE DEVICE HAD TO BE FORCIBLY WITHDRAWN, AND THE DISTAL END OF THE BALLOON REMAINED INFLATED. THE PHYSICIAN THEN PROCEEDED TO DEPLOY A STENT IN THE DISTAL LAD, FOLLOWED BY PLACEMENT OF A 4.50 X 24 MM SYNERGY? XD DES IN THE PROXIMAL LAD. DURING REMOVAL, SIMILAR DIFFICULTIES WERE ENCOUNTERED. THE DEVICE WAS REMOVED WITH FORCE, AND THE GUIDEWIRE WAS INADVERTENTLY EXTRACTED ALONG WITH IT. ONCE OUTSIDE THE BODY, THE PHYSICIAN HAD TO PULL THE GUIDEWIRE FROM THE BALLOON CATHETER WITH FORCE. UPON INSPECTION, THE PROXIMAL PORTION OF THE STENT BALLOON WAS STILL INFLATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO PATIENT COMPLICATIONS WERE REPORTED. IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469219 ↗
• MalfunctionOct 21, 2024Break; Break

  IT WAS REPORTED VIA MEDWATCH MW5159315 THAT SHAFT BREAK OCCURRED. A 4.50 X 24MM SYNERGY XD DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE SHEATH OF THE STENT BROKE OFF. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495963 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 4.50 X 24 MM SYNERGY XD DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE STENT BROKE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20326665 ↗
• MalfunctionAug 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING UNPACKING OF TWO 4.50 X 24MM SYNERGY XD DRUG-ELUTING STENTS, IT WAS NOTED THAT THE STENTS LOOKED DISLODGED. THE DEVICES WERE NEVER USED, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17635216 ↗
• MalfunctionFeb 9, 2023Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50 X 24MM SYNERGY XD DRUG ELUTING STENT WAS SELECTED USED. HOWEVER, DURING OPENING THE PACKAGE, THE DEVICE WAS SEEN BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYNERGY DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344090 ↗
• MalfunctionJul 2, 2021Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT REMOVAL DIFFICULTY OCCURRED. THE PATIENT PRESENTED WITH CHEST PAIN. A 4.50 X 24MM SYNERGY XD DRUG ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER DEPLOYMENT THERE WAS DIFFICULTY RETRIEVING THE BALLOON SYSTEM AS IT WAS LOCKED ON THE GUIDEWIRE. THE DEPLOYMENT BALLOON UNRAVELED NEAR THE GUIDEWIRE EXIT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12106315 ↗
• MalfunctionJun 14, 2021Mechanical Problem; Difficult to Remove; Unraveled Material

  PATIENT WITH HISTORY OF HYPERTENSION AND NEW ONSET CHEST PAIN AT REST WAS ADMITTED FOR A CARDIAC CATHETERIZATION WITH STENTING. STENT WITH IMPLEMENTATION BUT AFTER DEPLOYMENT, THERE WAS DIFFICULTY RETRIEVING THE BALLOON SYSTEM AS IT WAS LOCKED ON THE GUIDEWIRE OF THE SYNERGY XD EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM. DEPLOYMENT BALLOON UNRAVELED NEAR GUIDEWIRE EXIT. NO KNOWN HARM TO PATIENT.

  Patient problems: Chest Pain

  MAUDE report 11990818 ↗