Synchro2 S2SPS14300Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327459647), received between Sep 4, 2020 and Jan 3, 2025 — classified as 1 death, 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-1941-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. 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 21074243 ↗
• MalfunctionSep 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE CHRONIC INTRACRANIAL OCCLUSION PROCEDURE, DURING MANIPULATION WITHIN THE MICROCATHETER, THE GUIDEWIRE FRACTURED. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE FRACTURED GUIDEWIRE AS IT STILL REMAINED IN THE MICROCATHETER. 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 17818697 ↗
• MalfunctionJun 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ACUTE THROMBUS THROMBECTOMY PROCEDURE, WHEN THE SUBJECT GUIDEWIRE WAS INSERTED INTO THE PATIENTS ANATOMY, IT COULD NOT BE ROTATED. THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE AND FOUND 5CM FROM THE DISTAL TIP WAS STRETCHED AND FRACTURED. THE OPERATOR 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 17045421 ↗
• DeathDec 16, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE WHILE ADVANCING THE SUBJECT GUIDEWIRE THROUGH THE BALLOON CATHETER IN THE CAROTID SIPHON, PHYSICIAN NOTICED A KINK AND ON REMOVAL THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED. HE ATTEMPTED TO REMOVE THE FRAGMENT USING MULTIPLE STENT RETRIEVERS AND A SNARE DEVICES BUT WAS UNSUCCESSFUL. THE BROKEN FRAGMENT WAS REPORTED STENTED AGAINST THE VESSEL WALL SO IT WAS UNABLE TO RETRIEVED. THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE. IT WAS NOT CLEAR THAT THE EVENT WAS A DIRECT RESULT OF THE BROKEN SUBJECT GUIDEWIRE. THE PATIENT'S ANATOMY WAS VERY TORTUOUS AND THERE WAS A SURGICAL DELAY OF 2 HOURS. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT PASSED AWAY.

  Patient problems: Foreign Body In Patient; Hemorrhagic Stroke

  MAUDE report 13019907 ↗
• MalfunctionOct 14, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE ) BROKE OFF FROM DISTAL PORTION INSIDE THE PATIENT. NO FRAGMENTS LEFT INSIDE THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12636821 ↗
• InjurySep 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THERE WAS PERFORATION OF A SMALL VESSEL DISTAL TO THE LESION WHICH LED TO BLEEDING. PERFORATION WAS TREATED USING CODMAN GLUE AND BLEEDING CONTAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 10494992 ↗