Synchro SELECT SSTD300STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327508505), received between Dec 12, 2024 and Apr 2, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, RESISTANCE WAS ENCOUNTERED WITH THE SUBJECT DEVICE. ALSO, WHEN THE PHYSICIAN ATTEMPTED TO DELIVER THE SUBJECT DEVICE TO THE OCCLUDED SEGMENT THE TIP OF THE SUBJECT DEVICE GOT KINKED. THE PHYSICIAN REMOVED THE SUBJECT DEVICE ALONG WITH THE CATHETER AND FOUND THE TIP OF THE SUBJECT DEVICE TO BE FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24765986 ↗
• InjuryJan 9, 2026Fracture

  IT WAS REPORTED THAT DURING THE RECANALIZATION OF AN ACUTE OCCLUSION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) PROCEDURE, AFTER PLACING THE GUIDING CATHETER AT THE C2 SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA) AND A SUBJECT GUIDEWIRE WAS USED TO GUIDE A MICROCATHETER THROUGH THE LESION SITE. A STENT RETRIEVER WAS DEPLOYED ALONG THE MICROCATHETER, AND THE ASPIRATION CATHETER WAS ADVANCED ALONG THE STENT DELIVERY WIRE. A SINGLE THROMBECTOMY WAS PERFORMED USING A COMBINATION OF ASPIRATION AND PULLING, RESULTING IN THE REMOVAL OF SEVERAL BLOOD CLOTS. ANGIOGRAPHY SHOWED THAT THE VESSEL WAS RECANALIZED BUT EXHIBITED SIGNIFICANT STENOSIS. THE SUBJECT GUIDEWIRE WAS MANIPULATED TO CROSS THE LESION AND TO REACH THE M2 SEGMENT AND IT WAS OBSERVED UNDER IMAGING THAT THE SUBJECT GUIDEWIRE HAD FRACTURED APPROXIMATELY 10 CM FROM ITS TIP WITH PART OF THE RADIOPAQUE SEGMENT LOCATED IN THE MIDDLE CEREBRAL ARTERY (MCA) AND PART WITHIN THE INTERMEDIATE CATHETER. THE PHYSICIAN USED ANOTHER GUIDEWIRE TO SUPER SELECTIVELY ADVANCE TO THE M2 SEGMENT, ALONG WITH BALLOON AND CATHETER TO REMOVE THE FRACTURED SUBJECT GUIDEWIRE SUCCESSFULLY. AFTERWARD, ANOTHER BALLOON WAS SELECTED AND USED TO DILATE THE STENO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019697 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN SELECTED THE SUBJECT GUIDEWIRE TO ESTABLISH ACCESS. DURING THE SUPER-SELECTIVE PROCEDURE, THE PHYSICIAN SUSPECTED THAT THE SUBJECT GUIDEWIRE HAD FRACTURED. THE SUBJECT GUIDEWIRE WAS WITHDRAWN FROM THE BODY FOR INSPECTION, AND IT WAS CONFIRMED THAT THE SUBJECT GUIDEWIRE TIP HAD BROKEN AND STRETCHED. 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 23813563 ↗
• MalfunctionSep 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) PROCEDURE. THE SUBJECT GUIDEWIRE DISTAL TIP USED BY THE PHYSICIAN GOT FRACTURED INSIDE THE PATIENT'S BODY WITHOUT EXCESSIVE MANIPULATION. THE FRACTURED SUBJECT GUIDEWIRE, WHICH REMAINED WITHIN THE BALLOON CATHETER, WAS SUCCESSFULLY RETRIEVED. 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 23127072 ↗
• MalfunctionMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS DETACHED DURING PROCEDURE. THE PIECES OF THE TIP OF THE SUBJECT GUIDEWIRE WERE REMOVED TOGETHER WITH THE MICROCATHETER. THE PHYSICIAN WAS UNABLE TO ADVANCE THE SUBJECT GUIDEWIRE EITHER FORWARD OR BACKWARD (THE WIRE AND MICROCATHETER WERE POSITIONED IN THE HEPATIC ARTERY) AND ULTIMATELY HAD TO WITHDRAW IT TOGETHER WITH THE MICROCATHETER. 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 22046162 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A CHRONIC OCCLUSION OPENING PROCEDURE, PHYSICIAN SELECTED THE SUBJECT GUIDEWIRE FOR SUPERSELECTIVE CATHETERIZATION. WHEN THE SUBJECT GUIDEWIRE REACHED THE LESION, IT WAS UNABLE TO ADVANCE THROUGH THE STENOTIC SEGMENT BUT COULD BE RETRACTED. THE PHYSICIAN FELT THAT THE PUSH/PULL FORCE TRANSMISSION THROUGH THE SUBJECT GUIDEWIRE WAS ABNORMAL. THUS, FOR SAFETY REASONS WITHDREW THE SUBJECT GUIDEWIRE. UPON WITHDRAWAL, IT WAS FOUND THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED, BREAKING COMPLETELY APART UPON REMOVAL. THUS, 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21822665 ↗
• MalfunctionMar 14, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN EMERGENCY THROMBECTOMY COMBINED WITH CEREBROVASCULAR STENTING PROCEDURE FOR THE LEFT MIDDLE CEREBRAL ARTERY MCA, WHEN THE PHYSICIAN WAS ADVANCING THE SUBJECT GUIDEWIRE THROUGH MODERATELY TORTUOUS VESSELS, AFTER SEVERAL TORSIONS, THE PHYSICIAN NOTICED AN ABNORMAL SENSATION, CHARACTERIZED BY A DULL AND RESISTANT FEEL. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE SUBJECT GUIDEWIRE ALONG WITH THE MICROCATHETER AND REMOVED THE GUIDEWIRE FROM THE MICROCATHETER ON THE TABLE. UPON INSPECTION, IT WAS OBSERVED THAT THE SURFACE COATING OF THE SUBJECT GUIDEWIRE HAD PEELED OFF OVER A LENGTH OF 20-30MM AT THE DISTAL END, EXPOSING THE BARE METAL WIRE. AFTER CONFIRMING THAT NO COATING RESIDUE REMAINED WITHIN THE PATIENT'S BODY, A NEW GUIDEWIRE WAS USED TO CONTINUE AND COMPLETE THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21610577 ↗
• MalfunctionMar 11, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE DURING ANEURYSM AT THE BIFURCATION OF THE LEFT MIDDLE CAROTID ARTERY (MCA) PROCEDURE, THE OPERATOR PREPARED TO USED THE SUBJECT GUIDEWIRE ALONG WITH A MICROCATHETER TO PREPARE FOR SUPERSELECTIVE ANEURYSM CATHETERIZATION. HOWEVER, WHEN SHAPING THE SUBJECT GUIDEWIRE BEFORE USE, THE OPERATOR NOTICED THE COATING AT THE DISTAL END OF THE GUIDEWIRE WAS PEELING OFF. 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 21574800 ↗
• InjuryDec 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED DURING AIS (ACUTE ISCHEMIC STROKE) PROCEDURE. THE RETRIEVER WAS USED TO REMOVE THE FRACTURED FRAGMENT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20920705 ↗