Solitaire™ X SFR4-6-20-10Recalls & reported problems
Micro Therapeutics, Inc. · STENT SFR4-6-20-10 V03 SOLITIARE4 · Class 2
All models of Solitaire X (7)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00763000425692), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Physical Resistance/Sticking” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Physical Resistance/Sticking1
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, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS BEING TREATED FOR A RIGHT PROXIMAL M1 OCCLUSION. VESSEL TORTUOSITY WAS NORMAL. NIHSS 3 WITH MILD DYSRRHYTHMIA AND FACIAL DROOP ON DAY 1 POST OP. NIHSS 22 BASELINE. THE PHENOM WAS NOT REMOVED FROM THE PATIENT AND REPLACED WHEN THE SOLITAIRE WAS REMOVED DUE TO PRODUCT COMPLAINT, IT WAS USED WITH THE NEW SOLITAIRE TO SUCCESSFULLY TO DEPLOY THE STENT AND REMOVE THE CLOT. NO PATIENT SYMPTOMS WERE REPORTED RELATED O THE RESISTANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22438998 ↗
Other Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment devices
- Solitaire™ Platinum SFR3-4-40-10Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment10 deaths39 reports
- Trevo NXT 90314Stryker Corporation · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment1 death25 reports
- Solitaire™ Platinum SFR3-6-40-10Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment5 deaths23 reports
- Solitaire™ X SFR4-4-40-10Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment2 deaths18 reports
- Solitaire™ Platinum SFR3-4-20-10Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment1 report
- Solitaire™ Platinum SFR3-4-20-05Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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