SolitiareTM SFR2-6-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00847536020733), received between Jan 30, 2022 and Sep 15, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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.

• InjurySep 15, 2023Product Quality Problem; Product Quality Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED IT HAS ADJUDICATED THIS ADVERSE EVENT AS HEMORRHAGIC TRANSFORMATION OF INFARCT. ADJUDICATED THIS EVENT AS CAUSALLY RELATED WITH PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ischemia

  MAUDE report 17760640 ↗
• InjuryJul 12, 2023Product Quality Problem; Product Quality Problem

  2023 (B)(6) MPXR 1075186 (REP, HCP, FOR, SDY): MEDTRONIC RECEIVED A REPORT THAT POST PROCEDURE, THE PATIENT HAD FOCAL MOTOR SEIZURES. THE SPONSOR ASSESSED AS PROCEDURE RELATED AS POST MECHANICAL THROMBECTOMY STROKE EPILEPSY. URGENT CT WAS PLANNED. THE EVENT RESULTED IN HOSPITALIZATION FROM 2021 (B)(6) . LEVERA THERAPY DELIVERY SYSTEM WAS STARTED. THE OUTCOME IS RECOVERING/RESOLVING. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE STUDY PROCEDURE, DEVICES, UNDERLYING CONDITION OR DISEASE, OR DISEASE UNDERSTUDY, HOWEVER, THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND TO THE DISEASE UNDER STUDY. 2023-07-18 EMAIL (FOR, REP, HCP): ADDITIONAL INFORMATION RECEIVED REPORTED AT LATEST 3 MONTH FOLLOW UP, THE PATIENT NIHSS SCORE WAS 19 AND MRS SCORE WAS 5. AS PER EQ-5D-5L CRF VISIT AS OF (B)(6) 2022 PATIENT CHECKED, MOBILITY: ¿I HAVE SEVERE PROBLEMS IN WALKING ABOUT, SELF CARE: I AM UNABLE TO BATHE OR DRESS MYSELF, USUAL ACTIVITIES: I HAVE SEVERE PROBLEMS DOING MY USUAL ACTIVITIES, PAIN/DISCOMFORT: I HAVE SLIGHT PAIN OR DISCOMFORT, ANXIOUS/DEPRESSED: I AM SLIGHTLY ANXIOUS OR DEPRESSED, HEALTH SCORE: 50/100.¿ THE PATIENT EXPERIENCED FOCAL MOTOR SEIZURES

  Patient problems: Convulsion/Seizure; Epilepsy

  MAUDE report 17305185 ↗
• MalfunctionJan 30, 2022Break; Activation Failure; Physical Resistance/Sticking; Break; Activation Failure; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT WHEN THE SOLITAIRE WAS LOADED THROUGH THE MICROCATHETER, THE DISTAL SEGMENT OF THE SOLITAIRE WAS UNABLE TO OPEN AND THEY NEEDED TO GIVE IT MORE PRESSURE, THOUGH THE DEVICE STILL FAILED TO OPEN. WHEN PRESSURE WAS APPLIED, IT WAS NOTED THAT THE PUSHED WIRE WAS DAMAGED BECAUSE OF THE PROXIMAL PRESSURE APPLIED. THE STENT WAS NOT POSITIONED IN A BEND. A C ARM WAS USED DURING THE PROCEDURE. THE STENT WAS DEPLOYED A BIT DISTAL TO THE CLOT LOCATION. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS BEING TREATED FOR AN ISCHEMIC STROKE. THE PATIENT'S MRS BASELINE WAS 3 AND THE MRS PROCEDURE SCORE WAS NOTED AS THROMBECTOMY. THE PATIENT'S NIHSS SCORE BASELINE WAS 15 AND THEIR POST-PROCEDURE SCORE WAS 19. THE TICI SCORE BASELINE 2 AND TICI POST-PROCEDURE WAS 3. AN IV TPA WAS NOT CONTRAINDICATED. THERE WERE 2 PASSES MADE WITH THE DEVICE. THE PATIENT HAD MODERATE VESSEL TORTUOSITY. THE STROKE ONSET TO REPERFUSION TIME WAS 8. ANCILLARY DEVICES INCLUDE: A SHUTTLE SHEATH, A DAC 5F GUIDE CATHETER, AND A REBAR MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13390434 ↗