Solitaire XRecalls & reported problems across all models

We found 7 models of Solitaire X by Micro Therapeutics, Inc. in the FDA's device registry (GUDID). Together they are named in 106 adverse event reports in the FDA's MAUDE database, received between May 21, 2019 and Sep 14, 2026 — classified as 11 deaths, 41 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (52 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Solitaire X problems

Solitaire X models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Solitaire™ X SFR4-6-40-10

  CATHETER, THROMBUS RETRIEVER
  31 reports
• Solitaire™ X SFR4-6-40-10

  CATHETER, THROMBUS RETRIEVER
  2 deaths27 reports
• Solitaire™ X SFR4-3-20-10

  CATHETER, THROMBUS RETRIEVER
  6 deaths19 reports
• Solitaire™ X SFR4-4-40-10

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  2 deaths18 reports
• Solitaire™ X SFR4-4-40-10

  CATHETER, THROMBUS RETRIEVER
  1 death8 reports
• Solitaire™ X SFR4-3-40-10

  CATHETER, THROMBUS RETRIEVER
  2 reports
• Solitaire™ X SFR4-6-20-10

  Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
  1 report

Recent Solitaire X adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Break

  Medtronic received a report that the Solitaire fractured and remained inside the patient's body. It was reported that when the physician used the SFR4-6-40 in (b)(6), a Solitaire device fractured and remained inside the patient's body. Due to patient privacy concerns (personal data protection), the physician is currently unwilling to disclose the patient's condition. There was separation. The patient had vessel stenosis proximal to the thrombus site. The stent remains in the patient's internal carotid artery (ICA). The pushwire was discarded by the hospital after the procedure and is not available for return. The physician did not attempt to detach the stent. It was unknown if there were any patient symptoms or complications associated with this event. It was unknown if the reported device and any accessory devices prepared as indicated in the IFU. The patient is alive with no injury. Ancillary devices include a Phenom microcatheter.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 50753805 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Altered State of Consciousness; Embolism/Embolus; Headache; Intracranial Hemorrhage; Nervous System Injury; Respiratory Failure; Vasoconstriction

  MAUDE report 50382979 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cerebral Edema; Embolism/Embolus; Ischemia Stroke; Respiratory Failure; Vasoconstriction

  MAUDE report 50379094 ↗
• MalfunctionMar 18, 2026Break; Retraction Problem

  MEDTRONIC RECEIVED A REPORT OF SOLITAIRE STENT PUSHWIRE BREAK AND RESISTANCE WITH THE MARKSMAN MICROCATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ISCHEMIC STROKE IN THE A3 REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. INTRAVENOUS TISSUE PLASMINOGEN ACTIVATOR (IV TPA) WAS NOT CONTRAINDICATED. THE NUMBER OF PASSES WITH THE DEVICE WAS 2. IT WAS REPORTED THAT AFTER THE MICROCATHETER REACHED THE THROMBUS LOCATION, THE SOLITAIRE FR STENT WAS DELIVERED THROUGH THE THROMBUS. AFTER WAITING FOR INTEGRATION, THE STENT WAS PULLED TO PERFORM THROMBECTOMY. THE FIRST PULLING WAS SMOOTH. DURING THE SECOND PULLING, THE STENT BECAME STUCK IN THE MARKSMAN MICROCATHETER AND COULD NOT BE WITHDRAWN. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE OPERATOR GAVE A FORCEFUL PULL, RESULTING IN FRACTURE OF THE PROXIMAL END OF THE STENT AND BREAKAGE OF THE DELIVERY WIRE, WITH THE STENT STUCK INSIDE THE MICROCATHETER. THE STENT AND THE MICROCATHETER WERE THEN REPLACED, AND THE THROMBECTOMY WAS COMPLETED. THERE WAS PUSHWIRE BREAK/SEPARATION IN THE DISTAL SECTION. ALL BROKEN SEGMENTS OF THE PUSHWIRE WERE REMOVED FROM THE PATIENT. THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT'S BO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626393 ↗
• InjuryMar 3, 2026Retraction Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT AS OF RIGHT NOW THE CAUSE OF THE EVENT HAS NOT BEEN DETERMINED. THE CONSENSUS FROM THE HOSPITAL IS THAT INSIDE POLYMER OF THE BALLAST CAME OFF CAUSING IT TO UNRAVEL FROM THE INSIDE. THE ICA HEMORRHAGE OCCURRED DURING THE PROCEDURE, IT WAS NOTICED AFTER THE THIRD PASS. WHEN THEY PULLED THE SOLITAIRE OUT OF THE BALLAST. THEY NOTICED A METAL COIL COMING OUT OF THE BALLAST. THEY PULLED THE WIRE AND BALLAST OUT. THEN RE IMAGED THE CAROTID AND NOTICED THE HEMORRHAGE. THE PATIENT'S BASE LINE CONDITION WAS TICI 0, AND THE PATIENT¿S POST-THROMBECTOMY CONDITION IS CURRENTLY UNKNOWN. IT WAS STATED THAT OUTSIDE OF THE HEMORRHAGE AND VESSEL SACRIFICE TO TREAT THE HEMORRHAGE THEY WERE NOT ABLE TO SUCCESSFULLY TREAT THE PATIENT'S STROKE. AS OF NOW THE PATIENT IS SYMPTOMATIC FROM STROKE AND IT IS UNKNOWN IF THE EVENT MADE SYMPTOMS WORSE OR NOT. THE DEVICE WAS PREPARED AS INDICATED IN THE IFU. OVERALL THE PROCEDURE WAS UNABLE TO REMOVE CLOT FROM STROKE COILED OFF THE DISTAL ICA.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 24498550 ↗
• MalfunctionFeb 9, 2026Break

  MEDTRONIC RECEIVED A REPORT THAT DURING MECHANICAL THROMBECTOMY FOR A STROKE INTERVENTION PROCEDURE, AFTER THE SECOND PASS WAS MADE WITH THE SOLITAIRE FR4 STENT RETRIEVER AND IT WAS TAKEN OUT, IT WAS NOTICED THAT THE DEVICE HAD COME APART VERTICALLY, WITH COMPLETE FRACTURE FROM TOP TO BOTTOM OF THE DEVICE. GOOD BLOOD FLOW WAS RESTORED TO THE BRAIN, SO ANOTHER DEVICE WAS NOT NEEDED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24296837 ↗
• 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 ↗
• MalfunctionDec 8, 2025Break; Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Retraction Problem; Detachment of Device or Device Component; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR STENT ENCOUNTERED RESISTANCE, THERE WAS PUSHWIRE BREAK/SEPARATION, AND THE TIPS BROKE OFF IN M1 DURING RETRIEVAL. THE STENT REMAINED IN THE PATIENT AND THE BROKEN SEGMENT REMAINED IN M1. PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT WERE REPORTED AS "M1 GONE POST STROKE WHEN SOLITAIRE BROKE". STROKE ONSET TO REPERFUSION TIME WAS REPORTED AS 0. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; Stenosis

  MAUDE report 23743995 ↗
• MalfunctionNov 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY, WHEN INSERTION OF THE SOLITAIRE X REVASCULARIZATION DEVICE (SFR4) INTO THE MICROCATHETER WAS ATTEMPTED, RESISTANCE WAS FELT NEAR THE PROXIMAL END OF THE CATHETER. USE WAS DISCONTINUED AND THE SFR4 WAS REPLACED WITH A NEW SFR OF THE SAME MODEL, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CONTINUED AFTER SWITCHING TO A 3 MM DIAMETER DEVICE FROM ANOTHER COMPANY. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED A TREVO TRAK21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526328 ↗
• MalfunctionNov 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT DURING DELIVERY, WHEN INSERTION OF THE SOLITAIRE X REVASCULARIZATION DEVICE (SFR4) INTO THE MICROCATHETER WAS ATTEMPTED, RESISTANCE WAS FELT NEAR THE PROXIMAL END OF THE CATHETER. USE WAS DISCONTINUED AND THE SFR4 WAS REPLACED WITH A NEW SFR OF THE SAME MODEL, HOWEVER, THE SAME ISSUE OCCURRED. THE PROCEDURE WAS CONTINUED AFTER SWITCHING TO A 3 MM DIAMETER DEVICE FROM ANOTHER COMPANY.  NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED A TREVO TRAK21 MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23526280 ↗
• MalfunctionNov 11, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A NON-MEDTRONIC INTERMEDIATE CATHETER WAS ADVANCED TO THE DISTAL PORTION OF M1. THROMBECTOMY WAS ATTEMPTED SEVERAL TIMES USING A DIRECT ASPIRATION FIRST PASS TECHNIQUE (ADAPT), BUT THE THROMBUS COULD NOT BE RETRIEVED, SO THE SOLITAIRE FR THROMBUS RETRIEVAL STENT (SFR) WAS USED TO PERFORM A COMBINED TECHNIQUE. WHEN THE SFR WAS INSERTED INTO A NON-MEDTRONIC MICROCATHETER AND THE PUSH WIRE WAS PRESSED, THERE WAS A STRONGER RESISTANCE THAN USUAL. WHILE RESISTANCE WAS FELT, THE PUSH WIRE WAS CONTINUOUSLY ADVANCED, RESULTING IN THE SFR BECOMING STUCK WITHIN THE CATHETER. ALL MICROCATHETERS WERE REMOVED AND REPLACED WITH NEW ONES OF THE SAME MODEL. ADAPT WAS PERFORMED AGAIN USING A NON-MEDTRONIC INTERMEDIATE CATHETER, RESULTING IN RECANALIZATION, AND THE PROCEDURE WAS SAFELY COMPLETED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING THROMBECTOMY SURGERY FOR TREATMENT OF POOR BLOOD FLOW IN THE DISTAL (M2) SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDED AN 8F OPTIMA GUIDECAT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23525946 ↗
• MalfunctionNov 6, 2025Retraction Problem; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION REGARDING A SOLITAIRE X STENT RETRIEVER THAT COULD NOT BE RESHEATHED AND WAS DAMAGED. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT ISCHEMIC STROKE. THE SOLITAIRE AND ALL ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE FIRST PASS WAS COMPLETED NORMALLY. OUTSIDE THE PATIENT'S BODY, THE SOLITAIRE WAS RINSED/CLEANED NORMALLY. HOWEVER, WHEN RESHEATHING, THE SOLITAIRE STENT COULD NOT BE RESHEATHED AND "CRUMPLED ON ITSELF." THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23487996 ↗
• 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 ↗
• InjuryAug 15, 2025Break; Detachment of Device or Device Component; Physical Resistance/Sticking; Break; Detachment of Device or Device Component; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PHYSICIAN DID NOT FEEL THE DETACHED DEVICE HAD ANY EFFECT ON THE PATIENT OUTCOME. THE CAUSE OF THE EVENT WAS NOT DETERMINED. INITIALLY A CONTINUOUS SALINE FLUSH WAS NOT ADMINISTERED. HOWEVER, WHEN THIS WAS DISCOVERED, THE PHYSICIAN REMOVED AND DISCARDED THE CATHETER AND PULLED A NEW ONE WHERE CONTINUOUS FLUSH WAS MAINTAINED. THE INFORMATION IS CONFIRMED BY THE PHYSICIAN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22821608 ↗
• MalfunctionAug 11, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR M1D ISCHEMIC CEREBRAL INFARCTION. IT WAS NOTED THAT THE PATIENT'S BLOOD VESSEL TORTUOSITY WAS STRONG. THE THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE BASELINE WAS UNKNOWN AND AFTER THE PROCEDURE WAS 2B. INTRAVENOUS TPA WAS NOT CONTRAINDICATED, AND NOTABLY, THERE WERE ZERO PASSES WITH THE DEVICE DURING THE PROCEDURE. THE TIME REQUIRED FROM ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS 120 MINUTES IT WAS REPORTED THAT AFTER INDUCTION INTO M1D AFTER A MICROCATHETER, SOLITAIRE FR 3-40 WAS INSERTED INTO TREVOTRAK 21 MICROCATHETER. WHEN THE SOLITAIRE WAS INSERTED IN ABOUT TWO-THIRDS, THERE WAS A STRONG RESISTANCE IN THE CENTER OF THE CATHETER, BUT IT WAS STILL INSERTED. IT BECAME DIFFICULT TO INSERT THE STENT AFTERWARDS, SO THE STENT WAS REMOVED. UPON CHECKING THE STENT, KINKS WERE OBSERVED AT THE STENT JUNCTION. 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. ANCILLARY DEVICES INCLUDE A CHIKAI14 GUIDE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22770612 ↗

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