SolitiareTM SFR2-4-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536018464), received between Aug 27, 2018 and Jan 27, 2020 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 27, 2020Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE BECAME DETACHED UPON RETRIEVAL AND REMAINED IN PATIENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A RIGHT MCA ISHEMIC STROKE WITH MRS BASELINE: 5, MRS PROCEDURE: 5, NIHSS BASELINE: 20, NIHSS PRODECURE: 22, TICI SCORE FOR BASELINE AND POST-PROCEDURE: TICI 1. THE VESSEL TORTUOSITY WAS MODERATE AND THE PARENT VESSEL DIAMETER WAS 2.3MM. IT WAS REPORTED THAT THERE WAS PROXIMAL STENOSIS AT THE CAROTID BIFURCATION WHICH WAS PRE-DIALATED WITH A BALLOON. A GUIDING CATHETER WAS PLACED UP TO PETROUS SEGMENT OF THE INTERNAL CAROTID ARTERY. ONE MICROCATHETER WAS PLACED DISTAL TO THE OCCLUSION WITH HELP OF THE TRAXCESS WIRE. AT THIS POINT, CONTRAST SHOWED DISTAL ARTERIES WITH GOOD PERFUSION AND CONFIRMED THE M1 BLOCKAGE. THE SOLITAIRE WAS DEPLOYED. AFTER WAITING THREE MINUTES, THE SOLITAIRE WAS PULLED, BUT A LOT OF RESISTANCE WAS OBSERVED. WITH ANOTHER PULL, THE SOLITAIRE BECAME DETACHED AND ONLY THE WIRE CAME OUT OF THE BODY. ASSESSMENT OF THE SITUATION AND PATIENT SAFETY, IT WAS DECIDED TO NOT INTERVENE FURTHER AND THE CASE WAS STOPPED. IT WAS NOTED THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE, ONLY ONE PASS WAS MADE, THE MICROCATHE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9633775 ↗
• InjuryMay 13, 2019Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT THE SOLITAIRE FR DETACHED ON THE FOURTH PASS AND REMAINED IN THE PATIENT. PRIOR TO THE EVENT, THE REPORTED DEVICE AND ANCILLARY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE PHYSICIAN CROSSED THE NORMAL ARTERY IN THE DISTAL M2 AND THEN HAD DIFFICULT TIME PUSHING THE MICROCATHETER OVER THE WIRE DUE TO SEVERE TORTUOSITY FROM THE CCI TO THE DISTAL INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN HAD TRIED THREE PASSES TO OPEN THE T OCCLUSION IN THE VESSEL BUT WITHOUT SUCCESS AND THE REPORTED EVENT OCCURRED ON THE FOURTH ATTEMPT. THE PHYSICIAN TRIED TO SNARE THE DEVICE 4-5 TIMES BUT WAS NOT SUCCESSFUL. THE DETACHED SOLITAIRE REMAINED IN THE OCCLUDED ARTERY. THE PATIENT WAS UNDERGOING MECHANICAL THROMBECTOMY TO TREAT AN ISCHEMIC STROKE IN THE LEFT ICA T JUNCTION. THE BASELINE MRS WAS 4 AND BASELINE NIHSS WAS 17. POST PROCEDURE NIHSS WAS 17. THE BASELINE AND POST PROCEDURE TICI SCORE WERE 0. THE PATIENT¿S VASCULATURE WAS SEVERE IN TORTUOSITY. POST THE PROCEDURE THE PATIENT WAS REPORTED TO BE STABLE AND BEDRIDDEN. NO FURTHER MEDICAL INTERVENTION IS PLANNED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8605059 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT THERE WAS A PRESENCE OF EMBOLI IN A NEW TERRITORY FOLLOWING PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN ACUTE ISCHEMIC STROKE WITH A PRE-PROCEDURE NIHSS OF 15 AND A PRE-PROCEDURAL MTICI SCORE OF 0.

  Patient problems: Thromboembolism

  MAUDE report 7818953 ↗