Solitaire™ SFR3-4-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034006), received between May 28, 2019 and May 31, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionMay 31, 2019Failure to Advance

  THE SOLITAIRE REVASCULARIZATION DEVICE WOULD NOT FEED THROUGH THE MARKSMAN CATHETER. THE DEVICE NEVER MADE IT INTO PATIENT. THERE WERE NO COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8657845 ↗
• MalfunctionMay 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED REPORT THAT RESISTANCE WAS ENCOUNTERED WHEN THE SOLITAIRE PLATINUM WAS ATTEMPTED TO BE ADVANCED INTO THE CATHETER. THE SOLITAIRE DID NOT PASS THROUGH THE CATHETER. THE SOLITAIRE WAS ONLY ABLE TO ENTER ABOUT 12 INCHES. THIS EVENT OCCURRED DURING THE TREATMENT OF A LEFT SIDE M1 OCCLUSION. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE CASE. THERE WAS NO NOTABLE DAMAGE TO THE DEVICES PRIOR TO THEIR USE. RESISTANCE WAS ENCOUNTERED WHEN THE SOLITAIRE WAS RETRIEVED. THE SFR3 WAS IMMEDIATELY INSERTED INTO THE HUB AND ADVANCED WITHOUT FLUSHING. THE SOLITAIRE DEVICE WAS RETURNED TO MEDTRONIC AND OBSERVED TO BE SEPARATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8646324 ↗