Solitaire™ Platinum SFR3-4-20-05Recalls & reported problems
Micro Therapeutics, Inc. · STENT SFR3-4-20-05 V06 ENHANCED · Class 2
- 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 00847536034747), received between Mar 28, 2024 and Mar 28, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Embolism/Embolus1
- Ischemia Stroke1
- Stenosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT EXPERIENCED MULTIPLE SUBACUTE CEREBRAL INFARCTS IN THE LEFT CEREBRAL HEMISPHERE REGION. THE CAUSE OF THIS IS THAT THE LEFT MIDDLE CEREBRAL ARTERY REMAINS STENOTIC AND THERE IS REMNANT APPENDAGE EMBOLIZATION. ON REVIEW AT TIME OF DISCHARGE, THE HYPERDENSE SHADOW WAS REDUCED, THEN THE SUBJECT WAS DISCHARGED AS THE REQUIREMENT OF THE FAMILY. THE PATIENT'S BASELINE MODIFIED RANKIN SCALE (MRS) SCORE IS 0, BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) 15. THIS IS NOT A RECURRENT OR NEW STROKE. THE ADVERSE EVENT (AE) IS NOT RELATED TO THE SYSTEM OR PROCEDURE AND NOT RELATED TO UNDERLYING PATIENT CONDITION. AE DID NOT RESULT FROM DEVICE DEFICIENCY. THE ONSET DATE WAS 2023-04-06, AND THE ISSUE RECOVERED/RESOLVED ON 2023-04-10. PER SITE, THIS EVENT DID NOT LEAD TO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, OR MEDICAL INTERVENTION AND WAS NOT CONSIDERED LIFE-THREATENING. THE SITE ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THIS EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND DEVICE. PRE-PROCEDURE MTICI SCORE 0, FINAL POST-PROCEDURE MTICI 3. ANCILLARY DEVICES INCLUDE A ZHO
Patient problems: Embolism/Embolus; Ischemia Stroke; Stenosis
MAUDE report 18995715 ↗
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™ X SFR4-6-20-10Micro Therapeutics, Inc. · Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.