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Solitaire™ Platinum SFR3-4-20-10Recalls & reported problems

Micro Therapeutics, Inc. · STENT SFR3-4-20-10 V06 ENHANCED · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536034754), received between Jul 8, 2021 and Jul 8, 2021 — classified as 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

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionJul 8, 2021Break; Break

    MEDTRONIC RECEIVED A REPORT THAT THE SOLUMBRA TECHNIQUE WAS USED FOR THE STROKE PROCEDURE. AFTER A SINGLE PASS, IT WAS REALIZED THERE WAS A LOOSE METAL STRAND SEEN AT THE TIP OF THE SOLITAIRE STENT. IT WAS UNCERTAIN IF THE STRAND WAS FROM THE SOLITAIRE OR THE SOFIA 55 ASPIRATION CATHETER. THERE WAS NO INJURY REPORTED TO THE PATIENT AS A RESULT OF THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12135432 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.