SYNCHRO 10 M00316310Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 07613252187158), received between Jun 13, 2018 and Oct 21, 2025 — classified as 15 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (22 reports).

2 FDA recall records name this device's identifier, 2 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 23, 2024Open, Classified

   Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable limits of endotoxin levels; high levels of endotoxins may increase the risk of fever, shock and aseptic meningitis.

   Z-1909-2024 · Root cause: Process design · FDA record ↗

2. 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-1939-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE POLY TETRA FLUORO ETHYLENE (PTFE) COATING OVER THE SUBJECT DEVICE WAS NOTED TO BE PEELING. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY, AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348480 ↗
• MalfunctionMar 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING ARTERIOVENOUS MALFORMATION (AVM) CASE, PHYSICIAN ROTATED THE SUBJECT GUIDEWIRE FOR ADVANCEMENT IN PATIENT BODY, BUT THE DISTAL TIP WAS NOT MOVED FOLLOWING THE ROTATION AT PROXIMAL. ON WITHDRAWAL, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FOUND FRACTURED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846893 ↗
• MalfunctionDec 13, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE OPERATOR FOUND THE GUIDEWIRE (SUBJECT DEVICE) COATING PEELED OFF AT DISTAL DURING PREPARATION. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18319391 ↗
• MalfunctionNov 8, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING AN INTRACRANIAL ARTERIOVENOUS MALFORMATIONS EMBOLIZATION CASE WHEN THE PHYSICIAN WAS MANIPULATING THE SUBJECT GUIDEWIRE, THE GREEN POLYTETRAFLUOROETHYLENE (PTFE) COATING OF THE MIDDLE TO THE PROXIMAL PEELED OFF AND THE OPERATOR FELT BAD MANIPULATION OF THE SUBJECT GUIDEWIRE. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18097633 ↗
• MalfunctionNov 7, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS DETACHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085375 ↗
• MalfunctionOct 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING CANNULATION, THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE) DETACHED IN A NON-STRYKER MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PATIENT CONDITION FOLLOWING PROCEDURE IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17931944 ↗
• MalfunctionOct 11, 2023Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS NOTED TO BE PEELING. 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 17913955 ↗
• MalfunctionSep 21, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING ONE INTRACRANIAL ARTERIOVENOUS MALFORMATIONS EMBOLIZATION CASE, THE OPERATOR USED SUBJECT GUIDEWIRE TO WORK WITH NON-STRYKER MICROCATHETER TO BUILD ACCESS. HOWEVER LARGE AREA OF GREEN COATING PEELED OFF AT THE MIDDLE AND REAR OF THE SUBJECT GUIDEWIRE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17786801 ↗
• MalfunctionApr 24, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE REVEALED PEELING OF ITS PTFE COATING. 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 16802010 ↗
• InjuryMar 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE (SUBJECT DEVICE) BECAME DETACHED IN THE PATIENT, AND A PORTION IS STILL STUCK IN PATIENT. NO FURTHER INFORMATION IS AVAILABLE. ADDITIONAL INFORMATION RECEIVED STATED THAT WHEN THE PHYSICIAN WAS NAVIGATING THE MICROCATHETER IN THE LEFT OCCIPITAL ARTERY, THEY LOST PUSHABILITY OF THE SUBJECT GUIDEWIRE. WHEN THE SUBJECT GUIDEWIRE WAS PULLED BACK, THE PHYSICIAN NOTICED PART OF THE SUBJECT GUIDEWIRE BROKE OFF IN THE LEFT OCCIPITAL ARTERY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE BROKEN GUIDEWIRE WITH A SNARE AND OCCLUSION BALLOON, HOWEVER, THE GUIDEWIRE WAS NOT REMOVED AND IS CURRENTLY STILL IN THE LEFT OCCIPITAL ARTERY OFF THE LEFT EXTERNAL CAROTID.

  Patient problems: Foreign Body In Patient

  MAUDE report 16514558 ↗
• InjuryAug 5, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A LONG DURAL AV FISTULA CASE THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF AND DISLODGED DISTALLY IN THE PATIENT. A MICRO SNARE DEVICE WAS USED TO RETRIEVE THE TIP AND REMOVED IT FROM THE PATIENT. ACCORDING TO THE TECH, THE SUBJECT GUIDEWIRE WAS USED FOR SEVERAL HOURS BEFORE IT BROKE. ONYX WAS ALSO DELIVERED BY THE SAME MICROCATHETER DURING THE PROCEDURE PRIOR TO THE WIRE BREAKING. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176695 ↗
• MalfunctionMar 29, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE SUBJECT GUIDEWIRE WAS FOUND PEELED OFF. 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 13945252 ↗
• MalfunctionMar 19, 2022Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELED OFF. THEREFORE, THIS EVENT MEETS THE REQUIREMENTS OF A REPORTABLE EVENT WITH AN AWARENESS DATE OF (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827543 ↗
• MalfunctionOct 12, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING THE PROCEDURE WHILE SLIDING THE INTRODUCER OVER THE SUBJECT GUIDEWIRE THE PTFE COATING WAS PEELING OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12618983 ↗
• MalfunctionSep 27, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT COATING IS COMING OFF THE GUIDEWIRE (SUBJECT DEVICE). 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 12538170 ↗
• MalfunctionSep 16, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) WAS FOUND TO HAVE PARTICLES OF THE COATING PEELING OFF WHILE INSERTING INTO THE INTRODUCER. THE SUBJECT DEVICE WAS REMOVED AND DISCARDED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479028 ↗
• MalfunctionSep 7, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE PREPARATION, DURING INTRODUCING OF THE SUBJECT GUIDEWIRE INTO THE GUIDEWIRE INTRODUCER, SOME GREEN PARTICLES OF THE COATING PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436936 ↗
• MalfunctionAug 6, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN LOADED THE SUBJECT GUIDEWIRE BACK INTO THE INTRODUCER TO SHAPE IT BUT THE PTFE COATING OF THE SUBJECT GUIDEWIRE PEELED OFF. THE SUBJECT GUIDEWIRE WAS WITHDRAWN. 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 12291147 ↗
• MalfunctionJul 23, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING INTRODUCTION OF THE GUIDEWIRE (SUBJECT DEVICE) INTO THE INTRODUCER, SOME GREEN PARTICLES OF THE COATING PEELED OFF. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222156 ↗
• InjuryJun 22, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PATIENT'S VESSEL WAS BEING SELECTED WITH THE SUBJECT GUIDEWIRE AND A MICROCATHETER, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE BROKE OFF. THE FRACTURED PORTION OF THE SUBJECT GUIDEWIRE WAS RETRIEVED USING AN ADDITIONAL DEVICE. SURGICAL DELAY OF UNKNOWN LENGTH WAS REPORTED DURING THE PROCEDURE. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12046823 ↗
• InjuryJun 17, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING ONE DURAL ARTERIOVENOUS FISTULA CASE, THE DISTAL OF GUIDEWIRE WAS FRACTURED IN THE PATIENT'S VESSEL DUE TO THE TORTUOUS VESSEL CONDITION AND FRAGMENT LEFT INSIDE THE PATIENT. THEN, FINISHED THE PROCEDURE SUCCESSFULLY BY USING COILS TO OCCLUDE THE RELATED VESSEL AS IT WAS PART OF THE PLANNED PROCEDURE. THE PATIENT IS DOING OK AND NOT ADDED ON MEDICATION DUE TO THE VESSEL OCCLUSION.

  Patient problems: Foreign Body In Patient

  MAUDE report 12014284 ↗
• MalfunctionJun 16, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) WAS FOUND TO HAVE PARTICLES OF THE COATING PEELING OFF WHILE INSERTING INTO THE INTRODUCER. THE SUBJECT DEVICE WAS REMOVED AND DISCARDED. THE SUBJECT DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012335 ↗
• InjuryJun 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING THE DURAL ARTERIOVENOUS FISTULAE EMBOLIZATION CASE THE SUBJECT GUIDE WIRE WAS USED TO BRING THE MICRO CATHETER TO THE TARGET LESION. ON REACHING THE INTRACRANIAL VESSEL, PHYSICIAN WAS UNABLE TO CONTROL THE TIP OF THE SUBJECT GUIDE WIRE. HE TRIED TO WITHDRAW IT BUT THE TIP OF THE SUBJECT GUIDE WIRE GOT FRACTURED. A SNARE DEVICE WAS USED TO CAPTURE THE BROKEN TIP BUT IT ESCAPED FROM THE LOCATION. DSA WAS DONE AND THE PHYSICIAN FOUND THE TIP MOVED TO THE LOWER LIMB ARTERY. A JOINT CONSULTATION WAS ARRANGED BY THE HOSPITAL AND THE BROKEN TIP OF THE SUBJECT GUIDE WIRE WAS EXTRACTED OUT OF THE PATIENT'S BODY DUE TO WHICH THE SURGERY GOT DELAYED BY 5 HOURS. PATIENT IS DOING FINE AND IS ON SOME MEDICATIONS. 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 12001179 ↗
• MalfunctionMay 28, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING INTRODUCING OF THE SUBJECT GUIDEWIRE INTO THE ROTATING HEMOSTATIC VALVE (RHV) SOME GREEN PARTICLES OF THE COATING PEELED OF. THE SUBJECT DEVICE WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11903931 ↗
• MalfunctionMay 28, 2021Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE SUBJECT GUIDE WIRE WAS BEING INTRODUCED INTO THE ROTATING HEMOSTATIC VALVE (RHV), SOME GREEN PARTICLES OF THE COATING PEELED OF. THE SUBJECT GUIDE WIRE WAS WITHDRAWN AND ANOTHER WIRE WAS USED. THE PHYSICIAN COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899271 ↗