Synchro SELECT SSFT215STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 99 adverse event reports that list this exact device (DI 07613327508574), received between Sep 3, 2021 and Sep 30, 2026 — classified as 13 injuries, 86 malfunctions.

The most frequently reported specific device problem is “Fracture” (51 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 99 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Ruptured Aneurysm

  MAUDE report 50946978 ↗
• MalfunctionJul 10, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25775447 ↗
• MalfunctionMay 19, 2026Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS KINKED. THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT 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 25212439 ↗
• MalfunctionMar 6, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING MIDDLE MENINGEAL ARTERY MMA EMBOLIZATION BEFORE SURGICAL REMOVAL OF THE TUMOR, THE SUBJECT GUIDEWIRE WAS USED WITH THE MICROCATHETER. DESPITE RESHAPING THE SUBJECT GUIDEWIRE TIP AND MANEUVERING IT INTRAVASCULARLY TO APPROACH A SIGNIFICANTLY TORTUOUS LESION, ACCESS COULD NOT BE GAINED. WHEN IT WAS RETRIEVED FOR INSPECTION, THE TIP WAS NO LONGER AMENABLE TO RESHAPING. BOTH HYDROPHILIC COATING AND THE PTFE POLYTETRAFLUOROETHYLENE COATING SHOWED DAMAGE. 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 24538522 ↗
• MalfunctionFeb 16, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE HYPO TUBE OF THE SUBJECT GUIDEWIRE BROKE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24349373 ↗
• MalfunctionFeb 16, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348441 ↗
• MalfunctionFeb 16, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24348412 ↗
• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT DEVICE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227372 ↗
• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT DEVICE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24227370 ↗
• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT DEVICE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24226752 ↗
• MalfunctionJan 17, 2026Peeled/Delaminated

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT GUIDEWIRE SLUFFED OFF SOME PARTICLES WHEN PLACED INTO SALINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105516 ↗
• MalfunctionJan 2, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED, AND NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951542 ↗
• MalfunctionJan 2, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED, AND NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951540 ↗
• MalfunctionJan 2, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE HYPO TUBE OF THE SUBJECT GUIDEWIRE BROKE. THE GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO PATIENT WAS INVOLVED, AND NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951539 ↗
• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932248 ↗
• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932247 ↗
• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932242 ↗
• MalfunctionDec 31, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE PROXIMAL BOND JOINT OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932219 ↗
• MalfunctionNov 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PERCUTANEOUS INTRACRANIAL ARTERIAL THROMBECTOMY PROCEDURE THE PHYSICIAN NOTICED THE COATING PEELING OFF ON THE SUBJECT GUIDEWIRE. A TOMOGRAPHY IMAGING (CT SCAN) WAS PERFORMED AND REVEALED METALLIC ARTIFACTS. THE PROCEDURE WAS COMPLETED USING THE SAME GUIDEWIRE SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT. UPDATED: BASED ON THE INFORMATION FROM HOSPITAL, THE DNLYCT ONLY INDICATES THE PRESENCE OF METAL ARTIFACTS, SUGGESTING A POSSIBILITY OF COATING LEFT INSIDE PATIENT¿S VESSEL, BUT THERE WAS NO DIRECT EVIDENCE TO CONFIRM THIS HAS OCCURRED WITHIN THE PATIENT'S VESSELS. SUBSEQUENTLY, THE PATIENT DID NOT EXPERIENCE ANY VESSEL OCCLUSION OR STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457432 ↗
• InjuryOct 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED WHEN GAINING ACCESS INTO MMA BRANCH (MIDDLE MENINGEAL ARTERY). THEREFORE, THE STENT RETRIEVER WAS USED TO RETRIEVE THE FRACTURED PORTION FROM PATIENT¿S NEUROVASCULATURE SUCCESSFULLY. CONSEQUENTLY, THE PROCEDURE WAS TERMINATED. THE PATIENT IS DOING FINE AND THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. THERE WAS A SURGICAL DELAY OF 30 MINUTES DUE TO THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23257290 ↗
• MalfunctionSep 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, 10CM DISTAL TIP OF THE SUBJECT GUIDEWIRE SEPARATED FROM THE BODY OF THE WIRE WITHIN THE MICROCATHETER. THE DISTAL TIP AND THE WIRE WERE REMOVED FROM THE PATIENT. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23126782 ↗
• MalfunctionSep 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE PHYSICIAN NAVIGATED THE GUIDEWIRE (SUBJECT DEVICE) TO THE TARGET LOCATION THE GUIDEWIRE BECAME UNRESPONSIVE TO THE TORQUE CONTROL. THE PHYSICIAN WITHDREW THE GUIDEWIRE AND OBSERVED THAT THE DISTAL TIP WAS STRETCHED AND FRACTURED. 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 22979599 ↗
• MalfunctionAug 20, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE GUIDEWIRE WAS REMOVED FROM THE HOOP AND USED, THE COATING WAS PEELING OFF, MAKING IT IMPOSSIBLE TO USE. THE GUIDEWIRE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22851039 ↗
• MalfunctionAug 13, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER OPENING THE SUBJECT GUIDEWIRE PACKAGE, THE PHYSICIAN FOUND THAT THE TIP OF SUBJECT GUIDEWIRE WAS ABNORMAL WITH A FRACTURED COATING. 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 22800554 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED FOR AN INTERVENTIONAL EMBOLIZATION PROCEDURE FOR A RIGHT MCA (MIDDLE CEREBRAL ARTERY) M2 SEGMENT. WHEN ATTEMPTING TO SUPER SELECTIVELY ADVANCE THE SUBJECT GUIDEWIRE DEVICE IN COMBINATION WITH THE MICROCATHETER TO THE UPPER TRUNK OF THE M2 SEGMENT, THE SUBJECT GUIDEWIRE DEVICE BECAME UNRESPONSIVE TO TORQUE CONTROL. THE SUBJECT GUIDEWIRE DEVICE WAS WITHDRAWN FROM THE PATIENT¿S BODY AND OBSERVED THAT THE DISTAL END OF THE SUBJECT GUIDEWIRE EXHIBITED SIGNS OF FRACTURE AND STRETCHING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728871 ↗