SolitaireTM SFR3-4-20-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00847536027053), received between Mar 11, 2019 and Jul 20, 2019 — classified as 1 injury, 1 malfunction.

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.

• MalfunctionJul 20, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED NOTED THAT NO RESISTANCE WAS FELT, AND THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8809957 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE BLEEDING WAS CONFIRMED UNDER ANGIOGRAPHY AFTER RETRIEVING THE SOLITAIRE STENT FROM THE OCCLUSION SITE (M2). THE PHYSICIAN IMMEDIATELY EMBOLIZED THE BLEEDING SITE WITH 3 ED COILS. THE THROMBUS WAS RECOVERED AND THE PROCEDURE WAS FINISHED. THE PHYSICIAN NOTED THAT THE SOLITAIRE DEVICE DID NOT MALFUNCTION AND THAT THE DOCTOR MADE THE WRONG CHOICE IN DEVICE SELECTION FROM THE VIEWPOINT OF THE BLOOD VESSEL TORTUOSITY AS WELL AS THE ELDERLY PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8410000 ↗