SYNCHRO 14 M00313020Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613252186939), received between Aug 9, 2018 and Oct 16, 2024 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (12 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-1939-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionOct 16, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE TIP BROKE DURING THE PROCEDURE. 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 20463332 ↗
• MalfunctionOct 25, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE COATING WAS PEELING OFF FROM THE PROXIMAL END. 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 18002530 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) FRACTURED DURING USE AND THE UN-RETRIEVED PIECE OF GUIDEWIRE REMAINED IN THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT INTAKE CENTER ON 23-OCT-2023, CLARIFIED THAT SUBJECT GUIDEWIRE HAD FRACTURED OUTSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912179 ↗
• MalfunctionOct 11, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) FRACTURED DURING USE AND THE UN-RETRIEVED PIECE OF GUIDEWIRE REMAINED IN THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED FROM COMPLAINT INTAKE CENTER ON 23-OCT-2023, CLARIFIED THAT SUBJECT GUIDEWIRE HAD FRACTURED OUTSIDE THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911797 ↗
• MalfunctionJun 23, 2023Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE SUBJECT DEVICE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS NOTED TO BE PEELING. 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 17192061 ↗
• MalfunctionJan 25, 2022Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THE SUBJECT GUIDEWIRE (PTFE) POLYTETRAFLUOROETHYLENE COATING WAS PEELING/PEELED. 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 13344865 ↗
• MalfunctionDec 2, 2021Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THE SUBJECT GUIDEWIRE PTFE COATING WAS PEELING/PEELED. 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 12921885 ↗
• MalfunctionJun 28, 2021Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP WAS BROKEN DURING USE AND THE PTFE COATING WAS PEELING OR HAD PEELED AT THE PROXIMAL END. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12081703 ↗
• MalfunctionSep 8, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE THE PHYSICIAN REMOVED THE SUBJECT GUIDE WIRE FROM THE MICROCATHETER ITS PTFE COATING PEELED OFF FROM THE DISTAL END.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; No Consequences Or Impact To Patient

  MAUDE report 10505761 ↗
• MalfunctionJun 23, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE WHILE USING THE SUBJECT GUIDE WIRE, THE PHYSICIAN ENCOUNTERED RESISTANCE WHILE INSERTING THROUGH A BALLOON CATHETER. THE COATING ON THE DISTAL SUBJECT GUIDE WIRE WAS ALSO COMING OFF. ACCORDING TO THE PHYSICIAN, NO COATING WAS LEFT INSIDE THE PATIENT. THE PHYSICIAN REPLACED THE SUBJECT GUIDE WIRE WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10184786 ↗
• MalfunctionFeb 13, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PROCEDURE, WHEN THE PHYSICIAN TRIED TO REINSERT THE GUIDEWIRE (SUBJECT DEVICE) INTO THE MICROCATHETER, THE COATING OF THE GUIDEWIRE PEELED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9709169 ↗
• MalfunctionJul 29, 2019Peeled/Delaminated; Peeled/Delaminated

  DURING THE PROCEDURE, IT WAS REPORTED THAT THE GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS PEELED OFF. HENCE THE GUIDEWIRE WAS CHANGED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY AFTER. NO CLINICAL CONSEQUENCES REPORTED TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834830 ↗
• MalfunctionFeb 1, 2019Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE POLYTETRAFLUOROETHYLENE (PTFE) COATING ON THE GUIDEWIRE HAD PEELED. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8299062 ↗
• MalfunctionSep 8, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHILE TRYING TO INSERT THE SUBJECT DEVICE (GUIDEWIRE) TO MICROCATHETER, THE HYDROPHILIC COATING WAS REMOVED/PEELED OFF. THE PROCEDURE WAS COMPLETED WITH OTHER WIRE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7858442 ↗
• MalfunctionAug 9, 2018Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT FLAKING OF COATING OF THE GUIDEWIRE WAS OBSERVED BEFORE THE WIRE WAS INTRODUCED IN THE PATIENT. NO CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7770533 ↗