Solitaire™ SFR3-6-40-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536034044), received between May 21, 2019 and Sep 3, 2019 — classified as 2 injuries.

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.

• InjurySep 3, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT THIS SOLITAIRE STENT ENTANGLEMENT WITH NON-MEDTRONIC STENT AND LEFT IN THE PATIENT. THE PATIENT WAS UNDERGOING THROMBECTOMY TREATMENT FOR AN ISCHEMIC STROKE IN BASILAR ARTERY. THE VESSEL WAS MINIMAL TORTUOUS. IT WAS REPORTED THAT THE PATIENT WAS HAVING AN ACUTE ISCHEMIC STROKE. PATIENT ALSO HAD A STROKE THE DAY PRIOR IN WHICH TWO NON-MEDTRONIC STENTS HAD BEEN PLACED IN THE BASILAR ARTERY DUE TO ATHEROSCLEROTIC DISEASE AND SEVERE STENOSIS. ON THE DAY OF THE EVENT, PATIENT WAS HAVING ANOTHER ISCHEMIC STROKE WITH CLOT IN THE BASILAR ARTERY. PHYSICIAN ATTEMPTED TO RETRIEVE THE CLOT WITH THE SFR3-6-40-10 IN THE BASILAR ARTERY AND THE SOLITAIRE DEVICE BECAME STUCK ON THE EXISTING NON-MEDTRONIC STENT AND WAS UNABLE TO BE RESHEATHED OR REMOVED. AFTER MULTIPLE ATTEMPTS AT TRYING TO RE-SHEATH AND REMOVE THE SOLITAIRE DEVICE IT WAS DETERMINED THAT THE PUSH WIRE ON THE DEVICE NEEDED TO BE CUT AND FOR THE SOLITAIRE DEVICE TO REMAIN IN THE PATIENT. IT WAS DETERMINED THAT THE PUSH WIRE ON THE STENT WAS TO BE MANUALLY CUT AT THE GROIN AND THE REMAINDER OF THE DEVICE TO BE LEFT IN THE PATIENT. THE PUSH WIRE DID NOT BREAK OR SEPARATE ON ITS OWN. NO IMAGES AVAILABL

  Patient problems: Foreign Body In Patient

  MAUDE report 8955431 ↗
• InjuryMay 21, 2019Break; Break

  MEDTRONIC RECEIVED A REPORT THAT THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO REMOVE A HARD CLOT, WITH IT STATED THAT ON THE FOURTH ATTEMPT THE SOLITAIRE DEVICE ENCOUNTERED TENSION WHEN PULLING TOWARD THE TERMINUS, AND THE DEVICE DETACHING AS THE PHYSICIAN CONTINUED TO PULL. AS A RESULT THE DEVICE WAS IMPLANTED IN THE ICA. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE IN THE LEFT ICA. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. IT WAS NOTED THAT THE VESSEL WAS NOT TORTUOUS. THERE WAS NO STENOSIS PROXIMAL TO THE THROMBUS SITE, AND THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. 2 PASSES WERE MADE USING THE STENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 8628969 ↗