Solitaire™ X SFR4-4-40-10 (UDI 00847536034709)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00847536034709), received between May 9, 2024 and Jan 6, 2026 — classified as 1 death, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (3 reports).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Break; Material Deformation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED. THE VESSEL WAS SUCCESSFULLY OPENED IN THE PROCEDURE, AND THE PATIENT HAS RECOVERED. THE PATIENT'S PRESENTING SYMPTOM WAS A COMA. ONE PASS WAS MADE WITH THE SOLITAIRE PRIOR TO THE SEPARATION. THE SOLITAIRE FR STENT WAS FULLY REMOVED FROM THE PATIENT/VESSEL.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23979455 ↗
• MalfunctionSep 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE EVENT WAS NOT DEFINITIVELY DETERMINED BUT WAS PROBABLY RELATED TO VASCULAR TORTUOSITY. NO KINK OR DAMAGE WAS OBSERVED ON THE REBAR CATHETER. THE SURGEON RECALLED THAT THE PROXIMAL END OF THE SOLITAIRE PUSH WIRE WAS INTACT AND NOT DAMAGED. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076110 ↗
• MalfunctionAug 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE SOLITAIRE EXPERIENCED RESISTANCE DURING RETRIEVAL WITHIN THE DISTAL SECTION OF THE CATHETER. THE PATIENT WAS BEING TREATED FOR LARGE VESSEL OCCLUSION. THE STROKE ONSET TO REPERFUSION TIME WAS 2 HOURS. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCESS, THE STENT AND CATHETER WERE IN PLACE. HOWEVER, WHEN PULLING THE STENT BACK, THE STENT COULD NOT BE RETRIEVED INTO THE STENT CATHETER. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, IT WAS REMOVED FROM THE BODY. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738486 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT¿S THROMBUS HAD ESCAPED FROM THE ORIGINAL DISEASE. THE THROMBUS HAD ESCAPE TO AN M3 OCCLUSION. THE PATIENT RECOVERED/RESOLVED (B)(6) 2024. OTHER ACTIONS TAKEN: UROKINASE INTRAARTERIAL THROMBOLYTIC THERAPY. THE EVENT WAS NOT A RECURRENT OR NEW STROKE. THE AE WAS NOTED AS PROBABLY RELATED TO THE DISEASE UNDER STUDY. THE AE WAS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE. PATIENT DETAILS: MRS SCORE 0 AND NIHSS SCORE 10.THE EVENT WAS ASSESSED AS SAE CAUSAL RELATIONSHIP TO PROCEDURE AND POSSIBLE DEVICE RELATED. LOCATION OF PROXIMAL FACE OF CLOT: PRE-PROCEDURE MTICI SCORE 0 AND FINAL POST-PROCEDURE MTICI SCORE 2B. ANCILARY DEVICE: ASPIRATION CATHETER NIU CHUANG5F-125CM

  Patient problems: Thromboembolism

  MAUDE report 19767033 ↗
• MalfunctionJun 14, 2024Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE SEPARATION WAS NOT DETERMINED. THERE WERE 3 PASSES MADE WITH THE SOLITAIRE PRIOR TO THE SEPARATION. ON THE THIRD TIME, THE DEVICE WAS RETRIEVED INTO THE INTERMEDIATE CATHETER AND RESISTANCE WAS FELT. THE SOLITAIRE DEVICE WAS NOT TORQUED OR REPOSITIONED DURING DELIVERY OR RETRIEVAL. THE PATIENT DID NOT HAVE VESSEL STENOSIS PROXIMAL TO THE THROMBUS SITE; THROMBUS WAS LOCATED AT THE BIFURCATION. THE MICROCATHETER TIP COVERED THE SOLITAIRE DEVICE PROXIMAL MARKER DURING THE ATTEMPTED RETRIEVAL. THE BLOOD CLOT WAS HARD AND WAS CONSIDERED TO BE A CARDIOGENIC THROMBOSIS. THE SURGERY DID NOT COMPLETELY REMOVE THE BLOCKAGE, AND SOME BLOOD CLOTS REMAINED. THE SOLITAIRE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19536541 ↗
• InjuryMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED THAT THE EVENT WAS NOT RELATED TO THE PATIENT INDEX CONDITION. THE EVENT WAS POSSIBLY RELATED TO THE PATIENT CONDITION. THE EVENT MAY BE RELATED TO THE THROMBECTOMY/INDEX-PROCEDURE. THE EVENT WAS NOT RELATED TO THE MEDTRONIC DEVICES USED. ADDITIONAL INTERVENTION OR ADDITIONAL TREATMENT WAS REQUIRED TO ADDRESS THE ADVERSE EVENTS, SPECIFICALLY THE REMOVAL OF THE INTRACEREBRAL HEMATOMA. THE EVENT LED TO SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AS DEFINED BY: IN-PATIENT OR PROLONGED HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED THAT AFTER THE PROCEDURE, CROSSOVER SUPERSELECTIVE IMAGING OF THE RIGHT ILIAC ARTERY SHOWED PSEUDOANEURYSM FORMATION IN THE RIGHT FEMORAL ARTERY. NO TREATMENT WAS NOTED.

  Patient problems: Intracranial Hemorrhage; Pseudoaneurysm

  MAUDE report 19372174 ↗
• DeathMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE PATIENT UNDERWENT TREATMENT TO REMOVE THE INTRACEREBRAL HEMATOMA. THE PATIENT HAD NOT RECOVERED/RESOLVED. HEAD COMPUTER TOMOGRAPHY (CT) WITHOUT CONTRAST RESULTED IN TIGHT TEMPORAL LOBE HEMORRHAGE ON (B)(6) 2024. PATIENT NIHSS SCORE: 11. EVENT WAS ASSESSED AS SAFE AND POSSIBLY RELATED TO THE STUDY PROCEDURE.

  Patient problems: Intracranial Hemorrhage; Ischemia Stroke; Rupture

  MAUDE report 19319825 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT WHO WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE FOURTH PASS, WAS NOTED TO HAVE A DISSECTION OF THE INTERNAL CAROTID ARTERY (ICA). NO DEVICE MALFUNCTION WAS REPORTED. NO OTHER INFORMATION WAS REPORTED. MEDTRONIC RECEIVED A REPORT THAT THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) HAD LOCAL VASCULAR ROUGHNESS AND WAS CONSIDERED AN INTIMAL INJURY. THE PATIENT'S MRS SCORE WAS 0 AND NIHSS SCORE WAS 14. THE MEDICATION TIROFIBAN 0.25 MG WAS STARTED. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY PROCEDURE AND DEVICES UTILIZED DURING THE MECHANICAL THROMBECTOMY. THE ADVERSE EVENT WAS NOT RELATED TO THE DISEASE UNDER STUDY OR THE UNDERLYING CONDITION OR DISEASE. THE ADVERSE EVENT WAS NOT RELATED TO A DEVICE DEFICIENCY

  Patient problems: Vascular Dissection

  MAUDE report 19277873 ↗