Synchro SELECT SSUP215PRERecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327508635), received between Oct 18, 2022 and Mar 23, 2026 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2026Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THE SUBJECT GUIDEWIRE WAS STRETCHED AND BROKEN. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24670893 ↗
• MalfunctionFeb 18, 2026Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE TIP OF THE SUBJECT GUIDEWIRE FRACTURED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384372 ↗
• InjuryJan 22, 2026Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHILE ADVANCING THE GUIDEWIRE INTO THE MIDDLE CEREBRAL ARTERY THE GUIDEWIRE PROLAPSED AND HAD DIFFICULTY ENGAGING WITH THE TARGET SITE. WHEN ANOTHER ATTEMPT WAS MADE THE GUIDEWIRE WAS NOT PROVIDING THE FEEDBACK. THE PHYSICIAN REMOVED THE GUIDEWIRE ALONG WITH THE MICROCATHETER AND IDENTIFIED THE GUIDEWIRE TO BE FRACTURED. THE PHYSICIAN USED A SNARE DEVICE TO CAPTURE THE REMAINING GUIDEWIRE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF 10 MINUTES. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24147129 ↗
• MalfunctionAug 28, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING OF THE GUIDEWIRE (SUBJECT DEVICE) SCRAPPED OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913902 ↗
• MalfunctionMay 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, AN ELONGATED INTERNAL CAROTID ARTERY WITH MULTIPLE HAIRPIN BENDS MADE IT DIFFICULT TO REACH THE OCCLUSION. THE PHYSICIAN REMOVED THE MICROCATHETER WITH THE SUBJECT GUIDEWIRE FROM THE PATIENT. THE SUBJECT GUIDEWIRE AND MICROCATHETER WERE BROKEN. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22080108 ↗
• InjuryMar 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING ICA THROMBECTOMY PROCEDURE, DURING THE SEVENTH PASS, WHEN ATTEMPTED TO INSERT THE SUBJECT GUIDEWIRE INTO A NON-STRYKER ASPIRATION SYSTEM, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE COULD NOT BE INSERTED. THEREFORE, THE PROXIMAL END OF THE SUBJECT GUIDEWIRE WAS INSERTED FROM THE DISTAL TIP OF THE INNER CATHETER, THEN ACCESSED TO THE INTRAVASCULAR. RESISTANCE WAS FELT INTRAVASCULARLY WITH THE SUBJECT GUIDEWIRE, THE SUBJECT GUIDEWIRE WAS RETRACTED, RESULTING IN FRACTURED DISTAL TIP OF THE SUBJECT GUIDEWIRE. THE FRACTURED PART REMAINED IN THE BODY AND HENCE, A SNARE DEVICE WAS USED TO RETRIEVE IT. THE PROCEDURE WAS COMPLETED ALTHOUGH NOT ALL OF THE THROMBUS WAS RETRIEVED. THE PATIENT WAS PARALYZED PREOPERATIVELY, BUT THERE WAS NO CHANGE IN LEVEL OF CONSCIOUSNESS OR ENHANCEMENT OF PARALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21648662 ↗
• InjuryJan 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING RIGHT M1 MIDDLE CEREBRAL ARTERY ACUTE ISCHEMIC STROKE TREATMENT PROCEDURE, THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO ACCESS AN ARTERY IN THE PATIENT NEUROANATOMY. THE SUBJECT GUIDEWIRE THEN APPEARED TO BE STUCK AT A RIGHT ANGLE UNDER FLUOROSCOPIC AND THEN THE TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN AND WAS LEFT INSIDE THE PATIENT VESSEL. PHYSICIAN ATTEMPTED TO REMOVE THE BROKEN TIP OF THE SUBJECT GUIDEWIRE USING MICRO SNARE BUT FAILED TO DO SO. HEPARIN WAS GIVEN TO THE PATIENT. THE PATIENT DIED ON (B)(6) 2024, HOWEVER, THE PHYSICIAN STATED THAT THE DEATH IS NOT RELATED TO THE SUBJECT GUIDEWIRE AND IS CAUSED DUE TO THE PATIENT CONDITION FOR PRESENTATION TO HOSPITAL WITH ACUTE ISCHEMIC STROKE (AIS) RELATING TO INTRACRANIAL ATHEROSCLEROSIS DISEASE (ICAD). THE PATIENT AUTOPSY WAS DONE ON (B)(6) 2024. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18597036 ↗
• MalfunctionDec 21, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELED OFF WHEN THE INTRODUCER WAS USED. 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 18371558 ↗
• InjuryDec 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, A BALLOON GUIDE CATHETER WAS KINKED AND WHEN PHYSICIAN ATTEMPTED TO PASS THE SUBJECT GUIDEWIRE THROUGH THE KINKED AREA, THE SUBJECT GUIDEWIRE WAS BROKEN. THE BROKEN FRAGMENT OF THE SUBJECT GUIDEWIRE WAS LEFT WITHIN THE PATIENT ANATOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 18363241 ↗
• MalfunctionMay 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE SUBJECT GUIDEWIRE UNRAVELED AFTER BEING PULLED FROM A PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16959552 ↗
• MalfunctionOct 18, 2022Fracture; Fracture

  IT WAS REPORTED WHEN THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SUBJECT GUIDEWIRE, IT COULD NOT BE ROTATED WITH THE TORQUE DEVICE AND THE DISTAL TIP OF THE SUBJECT GUIDEWIRE DETACHED INSIDE THE CATHETER. THE SUBJECT GUIDEWIRE DISTAL TIP WAS REMOVED WITH THE CATHETER. BOTH DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625576 ↗