Synchro SELECT SSUP215STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 07613327508611), received between Jul 13, 2021 and Aug 27, 2026 — classified as 1 death, 15 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 18, 2024Open, Classified

   Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

   Z-1940-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Fracture

  It was reported during the thrombectomy procedure while advancing the subject guidewire, and resistance was encountered intravascularly. The distal tip fractured on the guidewire. The detached fragment and thrombus were retrieved using a stent retriever and aspiration catheter. The procedure was completed with no clinical consequences to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50465740 ↗
• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THE TIP OF THE SUBJECT GUIDEWIRE BROKE LOOSE, BUT COULD GET OUT OF THE PATIENT. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816781 ↗
• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT BROKEN DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757474 ↗
• MalfunctionApr 1, 2026Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT BROKEN DURING THE PROCEDURE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24757463 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING PROCEDURE TORQUE WAS APPLIED TO THE SUBJECT GUIDEWIRE AND WHEN ADVANCED WITHIN THE MICROCATHETER, IT GOT FRACTURED WITHIN THE SHAFT. THE SUBJECT GUIDEWIRE WAS REMOVED WITHE THE ENTIRE MICROCATHETER AND REPLACED WITH A NEW ONE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305769 ↗
• MalfunctionDec 16, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE GOT STUCK IN THE HUB OF THE MICROCATHETER DUE TO RESISTANCE AND THE HYDROPHILIC COATING WAS FOUND TO BE DAMAGED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819438 ↗
• MalfunctionOct 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) GOT BROKEN WITHIN THE MICROCATHETER DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23354619 ↗
• MalfunctionAug 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING ENDOVASCULAR TREATMENT OF AN INTRACRANIAL ANEURYSM PROCEDURE, WHILE REPOSITIONING, THE SUBJECT GUIDEWIRE DISTAL END GOT FRACTURED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22873191 ↗
• MalfunctionJul 28, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CEREBRAL EMBOLIZATION PROCEDURE, THE SUBJECT GUIDEWIRE WAS NAVIGATED TOGETHER WITH A MICROCATHETER. THE TIP OF THE SUBJECT GUIDEWIRE BROKE AND REMAINED INSIDE THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 20 MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636862 ↗
• InjuryApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN ATTEMPTED TO NAVIGATE TOWARDS THE MIDDLE CEREBRAL ARTERY THE DISTAL TIP OF GUIDEWIRE (SUBJECT DEVICE) GOT FRACTURED. THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE THE BROKEN PART. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859008 ↗
• InjuryApr 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTRAVASCULAR ADVANCEMENT OF THE SUBJECT GUIDEWIRE, THERE WAS RESISTANCE, AND THE SUBJECT GUIDEWIRE WAS STUCK IN THE VESSEL DUE TO SEVERE TORTUOUS ANATOMY AND TORQUE WAS ALSO APPLIED. THE SUBJECT GUIDEWIRE WAS FRACTURED WHEN IT WAS ABOUT TO BE PULLED OUT AND THE BROKEN FRAGMENT OF THE SUBJECT GUIDEWIRE WAS REMOVED USING A SNARE DEVICE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21848941 ↗
• MalfunctionMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A DURAL ARTERIOVENOUS FISTULA (DAVF) CASE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS FOUND TO BE KINKED DURING ADVANCING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF SUBJECT GUIDEWIRE WAS BROKEN FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644643 ↗
• MalfunctionMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A DURAL ARTERIOVENOUS FISTULA (DAVF) CASE, WHEN USING THE SUBJECT GUIDEWIRE TO GUIDE A MICROCATHETER TO THE TARGET VESSEL, THE GUIDEWIRE DID NOT MOVE AS INTENDED. THEREFORE, THE GUIDEWIRE WAS ONCE RETRACTED FROM THE MICROCATHETER TO RESHAPE THE DISTAL TIP, AND IT WAS FOUND THAT ABOUT 3CM FROM THE DISTAL TIP OF GUIDEWIRE WAS KINKED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT. THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF SUBJECT GUIDEWIRE WAS BROKEN FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21644642 ↗
• MalfunctionMar 5, 2025Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  IT WAS REPORTED THAT DURING D-AVF CASE, RESISTANCE WAS ENCOUNTERED DURING DELIVERY OF THE SUBJECT GUIDEWIRE WITHIN THE MICROCATHETER. WHEN THE SUBJECT GUIDEWIRE WAS RETRACTED, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS STRETCHED AND GOT FRACTURED. THE SUBJECT GUIDEWIRE INCLUDING THE FRACTURED PORTION WAS SAFELY REMOVED FROM THE MICROCATHETER. THE HYDROPHILIC COATING WAS DAMAGED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON 07 MAR 2025 STATED THAT THE ISSUE WAS NOTED WHEN THE DEVICE WAS OUTSIDE THE PATIENT ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21531881 ↗
• MalfunctionFeb 11, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE THROMBUS RETRIEVAL AS THE SUBJECT GUIDEWIRE WAS ADVANCED TO ACCESS THE PERIPHERAL LESION, THE DISTAL TIP OF THE GUIDEWIRE FRACTURED. THROMBUS RETRIEVAL WAS CONTINUED, AND WHEN SUCTION WAS APPLIED THROUGH THE ASPIRATION CATHETER, THE FRACTURED PART OF THE SUBJECT GUIDEWIRE WAS RETRIEVED ALONG WITH THE THROMBUS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355361 ↗
• InjuryJan 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL CAROTID (IC) ARTERY ASPIRATION PROCEDURE, THE OPERATOR USED A BALLOON GUIDE CATHETER AND RETRIEVED THE THROMBUS. HOWEVER, THE ANTERIOR CEREBRAL ARTERY (ACA) AND MIDDLE CEREBRAL ARTERY (MCA) WERE ALSO FOUND TO BE OCCLUDED. SO THE OPERATOR USED THE ASPIRATION CATHETER, THE MICROCATHETER AND THE SUBJECT GUIDEWIRE. A DIRECT ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) WAS PERFORMED FOR THE OCCLUSION OF THE MCA, AND THE THROMBUS WAS ASPIRATED AND RETRIEVED LEAVING THE PERIPHERAL VESSEL OCCLUDED. THE SHAPE WAS REAPPLIED TO THE SUBJECT GUIDEWIRE SEVERAL TIMES DURING THIS PROCESS. THE OPERATOR ADVANCED THE INTERMEDIATE CATHETER, MICROCATHETER AND THE SUBJECT GUIDEWIRE TO THE ACA TO RETRIEVE THE THROMBUS IN THE ACA. SINCE THE A1 WAS STEEPLY CURVED, A GENTLE CURVE WAS ADDED TO THE SHAPE OF THE SUBJECT GUIDEWIRE. WHILE CANNULATING A3 TO TREAT A LATERAL BRANCH AFFECTING THE MOTOR CORTEX OF THE FOOT, IT WAS FOUND UNDER FLUOROSCOPY THAT THE TIP OF THE GUIDEWIRE HAD BECOME FRACTURED. THE FRACTURED PART WAS REMOVED FROM THE PATIENT'S ANATOMY WITH A SNARE DEVICE. NO RESIDUAL MATERIAL OR BLEEDING WAS OBSERVED ON CONTRAST. THE PATIENT WAS EVALUATED AS TICI 2B AND THE P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242616 ↗
• MalfunctionOct 14, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE SUBJECT GUIDEWIRE BROKE OFF DURING THE THROMBECTOMY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20442237 ↗
• MalfunctionOct 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT A PIECE OF THE SUBJECT GUIDEWIRE BROKE OFF DURING THE THROMBECTOMY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431195 ↗
• MalfunctionSep 9, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS SNAPPED INSIDE THE PATIENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20174906 ↗
• InjuryAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SURGEON WAS TRYING TO GAIN ACCESS WITH THE SUBJECT GUIDEWIRE, THE DISTAL TIP OF THE WIRE (APPROX. THE LAST 6CM) BROKE OFF INSIDE THE PATIENT IN PROXIMAL INTERNAL CAROTID ARTERY (ICA). THE SURGEON RETRIEVED THE BROKEN PORTION WITH A MICRO SNARE. THE PATIENT WAS STABLE DURING THIS TIME BUT WAS NOT KEPT IN A HYPERTENSIVE STATE. THE SURGEON THEN HAD TO ABANDON THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939711 ↗
• InjuryJul 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL CAROTID ARTERY (ICA) THROMBECTOMY, THE SUBJECT GUIDEWIRE DEVICE WAS USED WITH OTHER DEVICES (VECTA CATHETER, INFINITY CATHETER) IN THE VESSEL AND TORTUOUS AORTIC ARCH AS THE RESISTANCE WAS ENCOUNTERED WHEN INSERTING THE CATHETER DEVICE. THEREFORE, THE SUBJECT GUIDEWIRE DEVICE WAS WITHDRAWN, AS THE TIP OF THE SUBJECT GUIDEWIRE SNAPPED OFF. THE SNARE WAS USED TO RETRIEVE THE FRACTURED FRAGMENT PART AND COMPLETED THE PROCEDURE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vasoconstriction

  MAUDE report 19818734 ↗
• InjuryJul 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACUTE ISCHEMIC STROKE (AIS) RIGHT M1 PROCEDURE WHEN ATTEMPTING TO CROSS A LESION WITH THE SUBJECT GUIDEWIRE, THE HARD CLOT REQUIRED MULTIPLE ATTEMPTS, RESULTING IN A APPROXIMATELY 5CM OF THE DISTAL TIP OF THE SUBJECT GUIDEWIRE TO BREAK OFF AND REMAIN IN THE PATIENTS ANATOMY. EFFORTS WERE MADE TO RETRIEVE THE FRAGMENT, BUT IT COULD NOT BE REMOVED, RESULTING IN A 120 MINUTES SURGICAL DELAY. RECANALIZATION COULD NOT BE OBTAINED, THEREFORE THE PROCEDURE WAS NOT COMPLETED. THE RESIDUAL FRAGMENT HAD NO IMPACT ON THE PATIENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19792240 ↗
• MalfunctionMay 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING MCA (MIDDLE CEREBRAL ARTERY) BIFURATION ANEURYSM EMBOLIZATION CASE, THE OPERATOR USED THE SUBJECT GUIDEWIRE TO BRING MICROCATHETER TO REACH TAIL OF M1 AND THEN THE OPERATOR FOUND THE SUBJECT GUIDEWIRE LOST ITS MANIPULATION. THE SUBJECT GUIDEWIRE WAS WITHDRAWN AND FOUND THE TIP 3-4CM WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED WITH ANOTHER GUIDEWIRE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT AFFECTED AS A RESULT OF THE EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299753 ↗
• InjuryApr 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE THE SUBJECT GUIDEWIRE TIP FRACTURED DURING USE. THE 1 CM FRACTURED SUBJECT GUIDEWIRE TIP WAS LEFT IN THE CAVERNOUS SINUS; HOWEVER, THE PLACE WHERE THE FRACTURED SUBJECT GUIDEWIRE TIP REMAINED WAS THE SPACE TO FILL WITH A COIL. IT WAS REPORTED THAT THE PATIENTS ANATOMY WAS SEVERELY TORTUOUS. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19102114 ↗
• InjuryMar 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING LEFT MIDDLE CEREBRAL ARTERY (MCA) STENOSIS CASE, RESISTANCE WAS ENCOUNTERED WHEN SUBJECT GUIDEWIRE WAS USED TO DELIVER BALLOON CATHETER. WHILE DOING SO, DISTAL TIP OF THE SUBJECT GUIDEWIRE GOT FRACTURED AND THE FRACTURED SEGMENT WHICH REMAINED IN PATIENT¿S BODY WAS TRIED TO RETRIEVE USING A SNARE DEVICE BUT FAILED. THEN, IT COULD BE SUCCESSFULLY REMOVED USING THROMBUS RETRIEVER. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815142 ↗