Solitaire™ X SFR4-4-40-10 (UDI 00763000425678)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000425678), received between May 26, 2021 and Aug 21, 2026 — classified as 2 deaths, 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (12 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionAug 7, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE APRO AND SOLITAIRE WERE DIFFICULT TO PULL FROM M1 SEGMENT. USED EXTRA FORCE AND WHEN IT WAS REMOVED IT WAS NOTICED THAT THE APRO HAD STRETCHED AND COIL WASN'T RIGHT. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THERE WAS RESISTANCE DURING THE PROCEDURE DURING RETRIEVAL. THE VESSEL WAS MODERATELY TORTUOUS. THE RESISTANCE WAS IN THE DISTAL SECTION OF THE CATHETER. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF LEFT MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC STROKE. THERE WERE 2 PASSES WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742166 ↗
• MalfunctionJul 30, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT AND COULD ONLY SPECULATE. A CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE IN ACCORDANCE WITH THE IFU. NO KINKS OR DAMAGE WERE OBSERVED ON THE CATHETER. THE TIP OF THE SOLITAIRE SHEATH WAS CONFIRMED TO HAVE BEEN SECURED INTO THE HUB OF THE MICROCATHETER. THE CHARACTERISTICS OF THE CLOT WERE REPORTED AS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22668989 ↗
• MalfunctionJul 18, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE TO THE CATHETER OR SOLITAIRE PUSHWIRE. THE TIP OF THE SOLITAIRE SHEATH WAS SECURED INTO THE HUB OF THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544220 ↗
• MalfunctionJul 11, 2025Material Deformation; Physical Resistance/Sticking; Material Deformation; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR MIDDLE CEREBRAL ARTERY (MCA) ISCHEMIC CEREBRAL (IC) INFARCTION. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PATIENT'S PRE-OPERATIVE TICI SCORE WAS 1, AND THE POST-OPERATIVE TICI SCORE IMPROVED TO 2B. THE PATIENT WAS TREATED WITH A THROMBECTOMY PROCEDURE USING A TPS (THROMBECTOMY PLATFORM SYSTEM). THE SOLITAIRE DEVICE WAS USED, WITH ZERO PASSES PERFORMED DURING THE PROCEDURE. THE TIME REQUIRED FROM THE ONSET OF CEREBRAL INFARCTION TO REVASCULARIZATION/REVASCULARIZE WAS 30 MINUTES. IT WAS REPORTED THAT THE PHENOM 21 AND SOLITAIRE WERE SELECTED. THE DEGREE OF VASCULAR TORTUOSITY LEADING TO THE MCA WAS MODERATE. THE OPTIMO 9FR WAS DELIVERED TO THE IC, AND THE PHENOM 21 WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE CHIKAI 14 WIRE, WHICH WAS ALSO PREPARED ACCORDING TO THE IFU, WAS SET UP. AFTER DELIVERING THE PHENOM 21 TO THE OCCLUSION SITE, AN ATTEMPT WAS MADE TO DELIVER THE SOLITAIRE STENT, WHICH HAD BEEN PREPARED ACCORDING TO THE IFU, INTO THE PHENOM 21. HOWEVER, STRONG RESISTANCE AND STIFFNESS WERE FELT. DESPITE SENSING ABNORMALITIES IN BOTH THE PHENOM 21 AND THE SOLITAIR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486179 ↗
• MalfunctionJun 20, 2025Break; Material Deformation; Packaging Problem; Break; Material Deformation; Packaging Problem

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE FR STENT WIRE BREAKAGE WAS OBSERVED IMMEDIATELY AFTER OPENING, SALINE IMMERSION, AND DURING INSERTION INTO THE CATHETER. THE WIRE WAS NOT USED AND WAS DISPOSED. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22302003 ↗
• MalfunctionApr 4, 2025Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT A SOLITAIRE 4X40 WAS PREPARED AND INSERTED INTO A PHENOM 21 MICROCATHETER. FRICTION WAS NOTICED WHILE ADVANCING THE SOLITAIRE THROUGH THE PHENOM 21 BUT THIS IS A NORMAL OCCURRENCE. THE SOLITAIRE 4X40 WAS DEPLOYED FROM THE LEFT M1 OF THE MIDDLE CEREBRAL ARTERY (MCA) DOWN INTO THE LEFT INTERNAL CAROTID ARTERY (ICA). AFTER A FEW MINUTES, THE SOLITAIRE WAS ATTEMPTED TO BE WITHDRAWN FROM THE PATIENT. AS THE SOLITAIRE 4X40 WAS PULLED INTO THE TIP OF THE APRO 70, THE SOLITAIRE DETACHED AT THE DISTAL PUSHER WIRE. SEVERAL ATTEMPTS WERE MADE TO REMOVE THE SOLITAIRE FROM THE LEFT ICA AND WERE FINALLY SUCCESSFUL AND TICI 2B RECANALIZATION WAS ACHIEVED. THERE WAS PUSHWIRE KINK/SEPARATION. THE PUSHWIRE WAS NOT TORQUED DURING THE PROCEDURE. RESISTANCE WAS ENCOUNTERED. THE PUSHWIRE BREAK OR SEPARATION WAS IN THE DISTAL SECTION. THE BROKEN SOLITAIRE WAS REMOVED FROM THE BODY BY USING TWO OTHER SOLITAIRE DEVICES INSIDE OF IT AND PULLED OUT SIMULTANEOUSLY. THE SOLITAIRE DEVICE SEPARATED ON THE DISTAL PUSHER WIRE AND THE SOLITAIRE BECAME COMPLETELY DETACHED IN THE ICA. THIS CAUSED AN OCCLUSION IN THE ARTERY UNTIL THE SOLITAIRE COULD BE REMOVED FROM THE PATIENT. THE DEV

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 21774436 ↗
• MalfunctionDec 10, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PHENOM 21 WAS IN POSITION ACROSS CLOT IN GOOD LOCATION. SOLITAIRE WENT INTO THE PHENOM 21 AND GOT STUCK ABOUT 10CM IN THE CATHETER AND NEVER MADE IT UP. THERE WAS RESISTANCE IN THE PROXIMAL SECTION OF THE CATHETER DURING DELIVERY. THE VESSEL WAS MODERATELY TORTUOUS. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS ONE PASS OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR STROKE THROMBECTOMY TREATMENT OF A DISTAL M2 ISCHEMIC STROKE. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. THE ACCESS VESSEL WAS THE DISTAL MIDDLE CEREBRAL ARTERY (MCA).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20896238 ↗
• MalfunctionAug 14, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE DID NOT SEPARATE. THE COMPONENTS OF THE DEVICE UNRAVELED. THE CAUSE OF THE EVENT WAS NOT DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981462 ↗
• DeathMay 11, 2022Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  MEDTRONIC RECEIVED INFORMATION THAT A LONG PIECE OF FILAMENT WAS LEFT IN A MICROCATHETER FROM A SOLITAIRE SENT. THE PRODUCT WAS REPLACE BY A MEDTRONIC PRODUCT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 14365775 ↗
• DeathFeb 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  MEDTRONIC RECEIVED INFORMATION REGARDING A PATIENT DEATH AFTER A SOLITAIRE SFR4 STENT DETACHED FROM A PUSHER WIRE DURING RETRIEVAL AND WAS LODGED IN THE VESSEL. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE STENT AND THE STENT WAS RETRIEVED SUCCESSFULLY BUT A TEAR IN THE VESSEL ENSUED. THE PATIENT BECAME DECEASED. AFTER USING A DIFFERENT 6X40 STENT ON FIRST PASS IT WAS SUCCESSFULLY POSITIONED AND THEN SWITCHED TO 4X40 STENT IN QUESTION AND THE EVENT HAPPENED WHEN RETRIEVING STENT INTO A REACT68 CATHETER. ANCILLARY DEVICES: REACT68.

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 13517691 ↗
• InjuryAug 30, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTED STENT WAS NOT A MEDTRONIC DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; Thromboembolism

  MAUDE report 12385883 ↗
• MalfunctionMay 27, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO ISSUE WITH THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897975 ↗
• MalfunctionMay 26, 2021Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PUSHWIRE SEPARATED AT THE DISTAL PORTION DURING RESHEATHING, AND THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. THE PATIENT WAS UNDERGOING TREATMENT FOR A STROKE IN THE M1 SEGMENT. THE POST PROCEDURE TICI SCORE WAS 3. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL, AND THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885260 ↗