Synchro SELECT SSUP300STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327508628), received between Feb 26, 2022 and Dec 5, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A SEVERE STENOSIS IN THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY, WHEN THE SUBJECT DELIVERY WIRE PASSED THROUGH THE STENOTIC LESION, THE TORQUE CONTROL FORCE OF THE WIRE WAS ALMOST ZERO, SO THE PHYSICIAN GRADUALLY WITHDREW IT FOR EXTERNAL INSPECTION AND FOUND THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS STRETCHED . HOWEVER, THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE DISTAL TIP WAS BROKEN/FRACTURED DURING USE. THE SUBJECT GUIDEWIRE 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 23727609 ↗
• InjuryMar 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING STENOSIS AT THE DISTAL END OF THE LEFT INTERNAL CAROTID ARTERY (ICA) PROCEDURE, THE OPERATOR DELIVERED INTERMEDIATE CATHETER TO THE C4 SEGMENT OF THE ICA. NEXT, THE OPERATOR USED THE SUBJECT GUIDEWIRE TO PASS THROUGH THE LESION AND ADVANCED IT TO THE M2 SEGMENT OF THE LEFT MIDDLE CAROTID ARTERY (MCA). ONCE THE SUBJECT GUIDEWIRE WAS IN POSITION, A RAPID-EXCHANGE BALLOON WAS USED FOR DILATION. POST-DILATION ANGIOGRAPHY SHOWED LESS-THAN-IDEAL RESULTS, PROMPTING THE WITHDRAWAL OF THE BALLOON. AT THIS POINT, IT WAS DISCOVERED THAT THE TIP OF THE SUBJECT GUIDEWIRE HAD FRACTURED WITHIN THE BLOOD VESSEL. THE OPERATOR IMMEDIATELY INSERTED ANOTHER GUIDEWIRE WITH A MICROCATHETER UP TO THE M1 SEGMENT OF THE MCA. AFTER WITHDRAWING THE SUBJECT GUIDEWIRE, A STENT WAS USED TO RETRIEVE THE FRACTURED GUIDEWIRE SUCCESSFULLY. 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 21540101 ↗
• InjuryFeb 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A BALLOON DILATION FOR A STENOSIS OF THE LEFT VERTEBRAL ARTERY PROCEDURE, A MICROCATHETER AND THE SUBJECT GUIDEWIRE WERE FIRST USED TO PERFORM A LESION CROSSING AND THEN GUIDING THE DEVICES FURTHER DISTALLY. THE VESSEL DISTAL TO THE STENOSIS WAS NARROW AND DIFFICULT TO GUIDE, AND THE PROCEDURE WAS BEING PERFORMED WHILE APPLYING TORQUE TO THE SUBJECT GUIDEWIRE. THE SUBJECT GUIDEWIRE COULD NO LONGER BE PUSHED AND PULLED, AND FLUOROSCOPIC IMAGES CONFIRMED THAT THE MIDDLE OF THE SUBJECT GUIDEWIRE WAS FRACTURED. THE FRACTURED GUIDEWIRE WAS RETRIEVED USING A MICRO SNARE. 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 18735417 ↗
• MalfunctionFeb 26, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AN INTRACRANIAL PTA (PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY ) PROCEDURE WAS PERFORMED IN A PATIENT. DURING THE PROCEDURE WHEN THE OPERATOR ATTEMPTED TO INSERT THE SUBJECT GUIDEWIRE INTO THE INTRODUCER, THE COATING ON THE PROXIMAL SIDE OF THE SUBJECT GUIDEWIRE PEELED OFF, THEREFORE THE USE OF THE SUBJECT GUIDEWIRE WAS DISCONTINUED. THE SUBJECT GUIDEWIRE 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 13608889 ↗
• MalfunctionFeb 26, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A VASCULAR DISSOCIATION PROCEDURE WAS PERFORMED IN A PATIENT IN INTRACRANIAL BLOOD VESSEL TO PLACE A STENT. INITIALLY DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN THE PHYSICIAN ADVANCED THE SUBJECT GUIDEWIRE THROUGH THE BALLOON CATHETER FOR PRE-EXTENSION. LATER WHEN THE STENT SYSTEM WAS ADVANCED OVER THE SUBJECT GUIDEWIRE, THE RESISTANCE WAS SO STRONG THAT IT WAS DETERMINED THAT THE SUBJECT GUIDEWIRE CANNOT BE USED ANYMORE BECAUSE OF THE POSITIONING ACCURACY. ACCORDING TO THE PHYSICIAN THE SUBJECT GUIDEWIRE MIGHT HAVE HAD THE COATING PROBLEM. THE SUBJECT GUIDEWIRE 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 13608648 ↗