SYNCHRO 14 M00313010Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 07613252186922), received between Nov 17, 2016 and Aug 31, 2026 — classified as 28 injuries, 192 malfunctions.

The most frequently reported specific device problem is “Fracture” (126 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Apr 23, 2024Class IIOpen, 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 · Recall details · FDA record ↗

2. Apr 18, 2024Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50517919 ↗
• MalfunctionAug 26, 2026Fracture

  It was reported during the procedure the subject guidewire could not be pushed inside the microcatheter. When the physician withdrew the device, the guidewire was found fractured near the distal tip. It 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 50453716 ↗
• MalfunctionJul 20, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883068 ↗
• MalfunctionJan 30, 2026Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS BROKEN AS THE PROXIMAL PART OF THE SUBJECT GUIDEWIRE HAS BEEN REMOVED MANUALLY. THE BROKEN SUBJECT GUIDEWIRE DISTAL TIP HAS BEEN REMOVED FROM THE ARTERY WITH THE STENT RETRIEVER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24222856 ↗
• MalfunctionOct 17, 2025Fracture; Fracture

  THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE WAS FOUND FRACTURED ALONG THE NITINOL TUBING WITH THE PLATINUM WIRE STRETCHED. THE DEVICE 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 23320025 ↗
• MalfunctionSep 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT GUIDEWIRE TIP BROKE OFF INSIDE THE BALLOON. 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 23099435 ↗
• MalfunctionSep 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT NO REACTION WAS RECEIVED FROM THE GUIDEWIRE (SUBJECT DEVICE) WHEN THE PHYSICIAN ATTEMPTED TO MANIPULATE THE GUIDEWIRE AT THE TARGET SITE. WHEN THE GUIDEWIRE WAS WITHDRAWN THE DISTAL TIP WAS NOTED TO BE 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 23067074 ↗
• MalfunctionSep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING STENT IMPLANTATION FOR MIDDLE CEREBRAL ARTERY STENOSIS, THE PHYSICIAN NOTICED THAT THE DISTAL END OF THE SUBJECT GUIDEWIRE DID NOT MOVE WHEN MANIPULATING IT AND UPON RE-EXAMINATION UNDER IMAGING, IT WAS DISCOVERED THAT THE TIP OF THE GUIDEWIRE HAD FRACTURED. THE PHYSICIAN ADVANCED THE MICROCATHETER TO A HIGH POSITION NEAR THE PROXIMAL POINT OF THE FRACTURED SUBJECT GUIDEWIRE PART LEFT INSIDE PATIENT'S BODY. THROUGH NEGATIVE PRESSURE ASPIRATION, THE FRACTURED SUBJECT GUIDEWIRE PART WAS DRAWN INTO THE MICROCATHETER, WHICH WAS THEN ENTIRELY WITHDRAWN FROM THE BODY. 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 22946616 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A BASILAR ARTERY (BA) THROMBECTOMY PROCEDURE, THE THROMBUS WAS DISTRIBUTED THROUGHOUT THE ENTIRE LENGTH OF THE BA. THE OPERATOR SELECTED A MICROCATHETER AND A SUBJECT GUIDEWIRE TO ESTABLISH THE PATHWAY. AFTER NORMAL FLUSHING AND WETTING OF THE PRODUCTS, THE MICROCATHETER WAS DELIVERED. WHEN THE MICROCATHETER REACHED THE PROXIMAL END OF THE THROMBUS, THE OPERATOR ADVANCED THE SUBJECT GUIDEWIRE THROUGH THE THROMBUS INTO THE POSTERIOR CEREBRAL ARTERY (PCA) IN ORDER TO DELIVER THE MICROCATHETER PAST THE THROMBUS. HOWEVER, WHEN THE SUBJECT GUIDEWIRE REACHED THE MIDDLE SEGMENT OF THE THROMBUS, SIGNIFICANT RESISTANCE WAS ENCOUNTERED, PREVENTING FURTHER ADVANCEMENT OF THE SUBJECT GUIDEWIRE. THE OPERATOR TWISTED AND ADJUSTED THE TIP OF THE SUBJECT GUIDEWIRE, BUT IT STILL COULD NOT PASS THROUGH THE LESION. NEXT, THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE INTO THE MICROCATHETER AND PLANNED TO RESHAPE THE TIP OF THE SUBJECT GUIDEWIRE BEFORE ATTEMPTING AGAIN. AFTER RETRACTING THE TIP OF THE GUIDEWIRE INTO THE MICROCATHETER, THE OPERATOR CONTINUED TO WITHDRAW THE SUBJECT GUIDEWIRE BUT FOUND THAT IT HAD FRACTURED APPROXIMATELY 35 CM FROM THE TIP. THE SUBJECT DEVICE WA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22731856 ↗
• MalfunctionAug 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF AN INFARCTION IN THE A2 SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA), THE OPERATOR SUCCESSFULLY DELIVERED A LONG SHEATH TO THE TARGET LOCATION AND A PATHWAY WAS ESTABLISHED USING AN INTERMEDIATE CATHETER, A MICROCATHETER, AND THE SUBJECT GUIDEWIRE. SUBSEQUENTLY, THE OPERATOR ATTEMPTED THROMBECTOMY USING A STENT RETRIEVER, BUT THE RESULTS WERE UNSATISFACTORY AFTER TWO ATTEMPTS. DURING THE THIRD SUPERSELECTIVE NAVIGATION WITH THE SUBJECT GUIDEWIRE, THE TORQUE CONTROL AT THE GUIDEWIRE TIP WAS INADEQUATE. UPON WITHDRAWAL, SLIGHT DEFORMATION OF THE SUBJECT GUIDEWIRE TIP WAS OBSERVED. WHEN FURTHER SUPERSELECTIVE NAVIGATION WAS ATTEMPTED WITH THE SAME GUIDEWIRE, IT COMPLETELY LOST TORQUE CONTROL. UPON RETRACTION AND INSPECTION, IT WAS FOUND THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED AND THE CORE WIRE REMAINED INTACT. 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 22731685 ↗
• MalfunctionJul 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF ANEURYSM AT THE ORIGIN OF THE POSTERIOR INFERIOR CEREBELLAR ARTERY (PICA) PROCEDURE, THE OPERATOR DELIVERED THE LONG SHEATH TO THE DESIRED POSITION, ESTABLISHED A TRI-AXIAL ACCESS USING A SUBJECT GUIDEWIRE, MICROCATHETER, AND INTERMEDIATE CATHETER. ONCE THE INTERMEDIATE CATHETER WAS IN PLACE, THE OPERATOR CONTINUED TO ADVANCE THE SUBJECT GUIDEWIRE FOR FURTHER SELECTION. HOWEVER, DURING THIS PROCESS, IT WAS FOUND THAT THE SUBJECT GUIDEWIRE COULD NOT BE MOVED. THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE AND DISCOVERED THAT APPROXIMATELY 10 CM OF THE DISTAL END HAD BROKEN OFF INSIDE THE PATIENT'S ANATOMY. THE OPERATOR USED A MICROCATHETER TO RETRIEVE THE BROKEN GUIDEWIRE SEGMENT. 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 22475168 ↗
• MalfunctionJun 30, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING AN OPHTHALMIC ARTERY SEGMENT ANEURYSM PROCEDURE, THE OPERATOR ESTABLISHED THE ACCESS PATHWAY USING THE SUBJECT GUIDEWIRE AND A MICROCATHETER. AFTER THE MICROCATHETER WAS DELIVERED INTO THE PATIENT'S ANATOMY, THE SUBJECT GUIDEWIRE WAS ADVANCED THROUGH IT. DURING THE ADVANCEMENT, RESISTANCE WAS ENCOUNTERED WHEN APPROXIMATELY HALF OF THE SUBJECT GUIDEWIRE'S LENGTH HAD BEEN DELIVERED, PREVENTING FURTHER FORWARD MOVEMENT. THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE AND FOUND THAT THE DISTAL END HAD BROKEN 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 22359016 ↗
• MalfunctionJun 26, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT GUIDEWIRE DISTAL TIP 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 22341204 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE AT THE LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE SUBJECT GUIDEWIRE BROKE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2025 STATES THAT THE PATIENT HAD A DIRECT BLEED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE. UPDATE: IT WAS REPORTED THAT DURING A PROCEDURE AT THE LEFT INTERNAL CAROTID ARTERY (ICA) ANEURYSM, THE DISTAL OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE TIP DETACHED FROM THE REMAINDER OF THE GUIDEWIRE WHILE ATTEMPTING TO CROSS THE GIANT ANEURYSM USING TORQUE. ADDITIONAL INFORMATION RECEIVED ON 12-MAY-2025 INDICATED THAT THE ADVERSE EVENT WAS NOT RELATED TO THE SUBJECT GUIDEWIRE. THE PHYSICIAN NOTED: ¿THE ANEURYSM SIZE WAS LARGE, AND THESE CASES CARRY A HIGH RISK OF RUPTURE.¿ THE PROCEDURE WAS SUCCESSFULLY COMPLETED THE FOLLOWING DAY USING A STENT AND COILING. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875313 ↗
• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBUS RETRIEVAL SURGERY, THE PHYSICIAN UTILIZED THE SUBJECT GUIDEWIRE TO SELECT THE EMBOLIZED BLOOD VESSEL. DURING THE SELECTION PROCESS, THE PHYSICIAN TORQUED THE SUBJECT GUIDEWIRE. HOWEVER, DURING THE TORQUE MANIPULATION, THE MIDDLE SECTION OF THE SUBJECT GUIDEWIRE BROKE WHEN POSITIONED AT THE DISTAL SEGMENT OF THE INTERNAL CAROTID ARTERY (ICA), ALTHOUGH THE CORE WIRE REMAINED PARTIALLY CONNECTED. THE PHYSICIAN CAREFULLY WITHDREW THE SUBJECT GUIDEWIRE SLOWLY TOWARDS THE PROXIMAL END UNTIL IT WAS FULLY WITHDRAWN INTO THE GUIDING CATHETER. SUBSEQUENTLY, WHEN WITHDRAWING THE GUIDING CATHETER, THE SUBJECT GUIDEWIRE COMPLETELY FRACTURED. 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 21590431 ↗
• MalfunctionMar 6, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE GUIDEWIRE DISTAL TIP 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 21538348 ↗
• MalfunctionMar 5, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE GUIDEWIRE DISTAL TIP 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 21531975 ↗
• MalfunctionMar 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 21510003 ↗
• InjuryJan 17, 2025Fracture; Fracture

  IT WAS REPORTED DURING AN ACUTE THROMBECTOMY CASE, THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED SO THE OPERATOR HAD TO TAKE THE FRACTURED PART OUT WITH A BALLOON. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. SURGICAL DELAY OF 60 MINUTES WAS OBSERVED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178724 ↗
• MalfunctionNov 19, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, COATING PEELED OFF PROXIMALLY AFTER THE TORQUE DEVICE WAS PUT OVER THE SUBJECT GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20728672 ↗
• MalfunctionNov 19, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, COATING PEELED OFF PROXIMALLY AFTER THE TORQUE DEVICE WAS PUT OVER THE SUBJECT GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20727623 ↗
• MalfunctionNov 15, 2024Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS, THE INVESTIGATION OF THE DEVICE REVEALED THAT THE SUBJECT GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695277 ↗
• MalfunctionNov 5, 2024Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND DURING DEVICE INVESTIGATION, IT WAS DISCOVERED THAT THE GUIDEWIRE (SUBJECT DEVICE) PTFE (POLYTETRAFLUOROETHYLENE) INNER COATING WAS PEELING FROM THE BODY OF THE GUIDEWIRE. 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 20611763 ↗
• MalfunctionOct 22, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT WHEN SHAPING THE SUBJECT GUIDEWIRE WITH SHAPING NEEDLE, THE COATING OF THE SUBJECT GUIDEWIRE PEELED OFF. 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 20507710 ↗
• MalfunctionSep 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN ADVANCING THE SUBJECT GUIDEWIRE TO THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA) THE OPERATOR NOTICED THAT THE DISTAL END OF THE SUBJECT GUIDEWIRE DID NOT RESPOND TO PROXIMAL MANIPULATION. THE SUBJECT GUIDEWIRE WAS WITHDRAWN, BUT THE DISTAL PORTION DID NOT COME OUT WITH IT. UPON REMOVAL, THE OPERATOR DISCOVERED THAT THE SUBJECT GUIDEWIRE HAD FRACTURED, THE FRACTURED SECTION OF THE GUIDEWIRE REMAINED INSIDE THE MIDDLE CATHETER. 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 20261724 ↗