SolitaireTM SFR3-6-20-10Recalls & reported problems
Micro Therapeutics, Inc. · STENT SFR3-6-20-10V01 US · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536020542), received between Dec 7, 2018 and Dec 7, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vasoconstriction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING MECHANICAL THROMBECTOMY PROCEDURE WITH THE SOLITAIRE DEVICE, PATIENT EXPERIENCE VASOSPASM AND ¿INTRAARTERIAL NIMODIPINE 2 MG.(VASOSPASM)¿ WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE TREATING HOSPITAL FOR AN ACUTE ISCHEMIC STROKE WITH A PRE-PROCEDURE NIHSS OF 18. THE SUBJECT HAD A PRE-PROCEDURAL MTICI SCORE OF 0 AND UNDERWENT MECHANICAL THROMBECTOMY PROCEDURE WITH THE SOLITAIRE STENT. IT WAS REPORTED THAT AFTER FINAL PASS WITH THE SOLITAIRE DEVICE, WE FOUND THAT THE LEFT INSULAR BRANCH OF MCA WAS STILL OCCLUDED WITH SUSPECTED VASOSPASM. THE TICI 2B WAS OBSERVED. THEN, INFUSED INTRA-ARTERIAL NIMODIPINE, AFTER THAT THE INSULAR BRANCH WAS COMPLETE RECANALIZED. TICI 3 WAS OBSERVED. THE VASOSPASM MAYBE OCCURRED AFTER RETRIEVED THE STENT OR ANYTIME DURING THROMBECTOMY. THE SUBJECT HAD A 24-HOUR POST PROCEDURE NIHSS OF 15. THE PATIENT HAS ATRIAL FIBRILLATION (AF), HT. AFTER THROMBECTOMY, PATIENT, SHE HAS IMPROVED POWER MOTOR WITH MILD APHASIA WITH CT SHOWED HEMORRHAGIC TRANSFORMATION AT LEFT BASAL GANGLIA. AFTER 2 WEEKS FROM THROMBECTOMY, THE WARFARIN WAS PRESCRIBED. THE DISCHARGE MRS SCORE WAS UPDATED TO 4. THE DISCHARGE N
Patient problems: Vasoconstriction
MAUDE report 8142737 ↗
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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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