SolitiareTM SFR2-4-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00847536020719), received between Mar 28, 2019 and Jul 1, 2019 — classified as 1 death, 3 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THE INTRACRANIAL HEMORRHAGE WAS OBSERVED VIA CT SCAN AND WAS ASYMPTOMATIC, NO FURTHER TREATMENT WAS NEEDED. THERE WAS NO SIGNIFICANT DISABILITY DUE TO THE ISSUE.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 8748130 ↗
• DeathApr 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE PASSED AWAY APPROXIMATELY 26 DAYS POST SUCCESSFUL MECHANICAL THROMBECTOMY PROCEDURE. THE PATIENT WAS UNDERGOING MECHANICAL THROMBECTOMY FOR TREATMENT OF AN ACUTE ISCHEMIC STROKE. PRIOR TO THE EVENT, THE SUBJECT HAD A PRE-PROCEDURE NIHSS OF 25. SUBJECT HAD A PRE-PROCEDURAL MTICI SCORE OF 0. FINAL PASS WITH SOLITAIRE RESULTED IN TICI OF 2B. 24 HOURS POST PROCEDURE, THE PATIENT HAD NIHSS OF 19 AND WAS DISCHARGED HOME 6 DAYS POST PROCEDURE WITH MRS OF 4 AND NIHSS OF 6. THE REASON FOR DEATH WAS UNKNOWN.

  Patient problems: Death

  MAUDE report 8493779 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THROUGH CLINICAL STUDY THAT PATIENT EXPERIENCED CEREBRAL INFARCTION WITH HEMORRHAGIC TRANSFORMATION THAT WAS ASSESSED BY THE PI AS SERIOUS WITH AN INDETERMINATE CAUSALITY.

  Patient problems: Infarction, Cerebral

  MAUDE report 8461573 ↗
• InjuryMar 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THROUGH CLINICAL STUDY THAT (B)(6) 2018, SUBJECT BECAME CONSCIOUS, NO HEAD-ACHE, NO VOMITING, LEFT SIDE WEAKNESS, MUSCLE FORCE WAS 2/5 08:58 (B)(6) 2018, NON-CONTRAST CT SCAN: CEREBRAL INFARCTION WITH HEMORRHAGIC TRANSFORMATION PH1 NO TREATMENT WAS PERFORMED, NO MORE IMAGING WAS PERFORMED. ON (B)(6) 2018, SUBJECT RECOVERED, COULD WALK WITHOUT ASSISTANCE, SUBJECT WAS DISCHARGED ON (B)(6) 2018 CEREBRAL INFARCTION WITH HEMORRHAGIC TRANSFORMATION IS ASYMPTOMATICÀ NO TREATMENT WAS PERFORMED THE PATIENT EXPERIENCED CEREBRAL INFARCTION WITH HEMORRHAGIC TRANSFORMATION POST PROCEDURE: NON CONTRAST CT PERFORMED AT ABOUT 23 H OURS AFTER PROCEDURE, THE EVENT WAS OBSERVED THE PATIENT IS ASYMPTOMATIC.

  Patient problems: Infarction, Cerebral

  MAUDE report 8461535 ↗