Solitaire™ X SFR4-3-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000367626), received between Apr 10, 2023 and Aug 11, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR M1D ISCHEMIC CEREBRAL INFARCTION. IT WAS NOTED THAT THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS STRONG. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE BASELINE WAS UNKNOWN AND AFTER THE PROCEDURE WAS 2B. INTRAVENOUS TPA WAS NOT CONTRAINDICATED, AND NOTABLY, THERE WERE ZERO PASSES WITH THE DEVICE DURING THE PROCEDURE. THE TIME REQUIRED FROM ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS 120 MINUTES IT WAS REPORTED THAT AFTER INDUCTION INTO M1D AFTER A MICROCATHETER, SOLITAIRE FR 3-40 WAS INSERTED INTO TREVOTRAK 21 MICROCATHETER. WHEN THE SOLITAIRE WAS INSERTED IN ABOUT TWO-THIRDS, THERE WAS A STRONG RESISTANCE IN THE CENTER OF THE CATHETER, BUT IT WAS STILL INSERTED. IT BECAME DIFFICULT TO INSERT THE STENT AFTERWARDS, SO THE STENT WAS REMOVED. UPON CHECKING THE STENT, KINKS WERE OBSERVED AT THE STENT JUNCTION. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A CHIKAI14 GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770612 ↗
• MalfunctionApr 10, 2023Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE STENT PACKAGE WAS OPENED AND THE STENT WAS HYDRATED. A REBAR18 WAS USED TO DELIVER THE STENT. AFTER THE STENT WAS IN PLACE, IT WAS DEPLOYED AND PULLED BACK, BUT THE STENT BROKE. IT WAS UNKNOWN IF ANY PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16706721 ↗