Solitaire 2 SFR2-4-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00836462016385), received between Jun 9, 2019 and Jun 9, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION: THE EVENT WAS DIAGNOSED BY CTA IMAGE CONDUCTED AT 24 ± 8 HRS POST STUDY PROCEDURE. CTA IMAGE SHOWED IMAGE OF SUBARACHNOID HEMORRHAGE AROUND CEREBRAL PEDUNCLE. NHISS SCORE POST PROCEDURE WAS NOT DONE. NHISS SCORE WAS 10 AT THE TIME NEAREST TO THE EVENT ONSET. THE LOCATION OF THE INTRACRANIAL BLEEDING AROUND THE CEREBRAL PEDUNCLE. PATIENT RECEIVED OXYGEN SUPPORT, PAIN RELIEVE DRUG AND NEED FOR CLOSE FOLLOW UP BY MONITOR. PATIENT¿S CONDITION WAS STABLE. PATIENT WAS CONSCIOUS, COULD BREATHE WITHOUT OXYGEN SUPPORT. HIS HEADACHE RELIEVED. HIS TENSION WAS STABLE. LEFT PARALYSIS WITH 3/5 MUSCLE¿S FORT RECOVERED. PATIENT WAS DISCHARGED TO REHABILITATION CENTER. NHISS SCORE AT DISCHARGE WAS 6. THEE SEQUELAE THE SUBJECT DEVELOPED AT RESOLUTION: THE PATIENT HAD LEFT PARALYSIS MEDICAL HISTORY: HYPERTENSION WITH REGULAR TREATMENT

  Patient problems: Headache; Intracranial Hemorrhage; Paralysis; Vasoconstriction

  MAUDE report 8681374 ↗