Synchro SELECT SSTD215PRERecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07613327508512), received between Oct 22, 2021 and Apr 3, 2025 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert

  IT WAS REPORTED THAT DURING THE PROCEDURE AFTER MULTIPLE ATTEMPTS OF PASSING THE SUBJECT GUIDEWIRE THROUGH THE MICROCATHETER, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE BROKE AND CAME OUT. THERE WAS A SURGICAL DELAY OF 15 MIN DUE TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761920 ↗
• MalfunctionOct 24, 2024Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT AT PRODUCT OPENING THE CLOSURE SEAL OF THE SUBJECT GUIDEWIRE PACKAGING WAS FOUND TO BE UNATTACHED. ADDITIONAL INFORMATION RECEIVED ON 03 OCT 2024 THAT INNER POUCH LOOKED IT MIGHT NOT BE PARTIALLY CLOSED. 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 20523570 ↗
• InjuryJul 22, 2024Peeled/Delaminated; Peeled/Delaminated

  AFTER THE ACUTE ISCHEMIC STROKE (AIS) PROCEDURE, THE PHYSICIAN REPORTED IT WAS POSSIBLE THAT A PART OF THE SUBJECT GUIDEWIRE WAS LEFT IN THE PATIENTS BODY. DURING THE POSTOPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN, IT SHOWED HIGH VALUES INDICATIVE OF A METALLIC COMPONENT AND CONTRAST SCAN REVEALED AN OBSTRUCTION IN THE ANTERIOR COMMUNICATING ARTERY (ACA) THE PHYSICIAN STATED THE SUBJECT GUIDEWIRE MANIPULATION WAS SOMEWHAT AGGRESSIVE. WHEN THE SUBJECT GUIDEWIRE WAS EXAMINED, IT APPEARED THE TIP WAS PEELING. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion

  MAUDE report 19794953 ↗
• MalfunctionMay 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED TO GAIN ACCESS TO A GIANT CAVERNOUS ANEURYSM IN AN ATTEMPT TO TREAT WITH A FLOW DIVERTING STENT. ACCESS PROVED TO BE EXTREMELY DIFFICULT, AND THE SUBJECT GUIDEWIRE WAS USED IN CONJUNCTION WITH TENZING 5F MICROCATHETER TO TRY AND GET ACCESS THROUGH THE OUTFLOW OF THE ANEURYSM. DURING THIS, THE PHYSICIAN REALIZED THAT THE SUBJECT GUIDEWIRE WAS NOT RESPONDING TO THE MANIPULATION. THE PHYSICIANS THOUGHT THE SUBJECT GUIDEWIRE COULD HAVE BROKEN, DUE TO THE FORCE THAT WAS EXERTED TRYING TO GET TENZING 5F MICROCATHETER THROUGH THE OUTFLOW. AFTER PULLING THE SYSTEM (TENZING AND SOFIA 5F MICROCATHETERS) OUT, IT WAS DISCOVERED THAT THE DISTAL PORTION OF THE SUBJECT GUIDEWIRE BROKE OFF AND THE SUBJECT GUIDEWIRE WAS ABLE TO BE RETRIEVED AND NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO COMPLICATIONS DUE TO THE SUBJECT WIRE. THE PATIENT WAS UNABLE TO BE TREATED DUE TO THE ANATOMY BEING SO TORTUOUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19392428 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  THE SUBJECT GUIDEWIRE 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 18258929 ↗
• MalfunctionAug 9, 2023Peeled/Delaminated; Peeled/Delaminated

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) 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 17490985 ↗
• MalfunctionAug 2, 2023Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446344 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  DURING STRYKER INTERNAL R&D SIMULATED USE TESTING IN A SILICONE MODEL, OPERATOR NOTICED THAT THE SUBJECT GUIDEWIRE WAS NOT RESPONDING TO TORQUE APPLIED. THE OPERATOR PULLED SUBJECT GUIDEWIRE OUT OF THE MODEL AND FOUND DISTAL HYPOTUBE OF SUBJECT GUIDEWIRE FRACTURED. THE SUBJECT GUIDEWIRE WAS USED IN A BENCH TOP FLOW MODEL IN A LAB AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008550 ↗
• MalfunctionMay 26, 2023Fracture; Fracture

  DURING STRYKER INTERNAL R&D SIMULATED USE TESTING IN A SILICONE MODEL, OPERATOR NOTICED THAT THE SUBJECT GUIDEWIRE WAS NOT RESPONDING TO TORQUE APPLIED. THE OPERATOR PULLED SUBJECT GUIDEWIRE OUT OF THE MODEL AND FOUND DISTAL HYPOTUBE OF SUBJECT GUIDEWIRE FRACTURED. THE SUBJECT GUIDEWIRE WAS USED IN A BENCH TOP FLOW MODEL IN A LAB AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17008549 ↗
• MalfunctionApr 17, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT PTFE POLYTETRAFLUOROETHYLENE COATING OF SUBJECT GUIDEWIRE WAS PEELING. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756639 ↗
• MalfunctionOct 21, 2022Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING OF THE GUIDEWIRE (SUBJECT DEVICE) WAS PEELED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15650458 ↗
• MalfunctionOct 11, 2022Peeled/Delaminated; Peeled/Delaminated

  DURING THE COIL EMBOLIZATION OF A RUPTURED CEREBRAL ANEURYSM, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN INSERTING THE SUBJECT GUIDEWIRE INTO THE MICROCATHETER THROUGH THE INTRODUCER SHEATH. POST PROCEDURE, PEELING OF PTFE WAS NOTICED ON THE PROXIMAL OF SUBJECT GUIDEWIRE. THE PHYSICIAN CONFIRMED NO PIECES OF THE PEELING REMAIN IN THE PATIENT'S ANATOMY. 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 15580519 ↗
• MalfunctionSep 19, 2022Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE PTFE (POLYTETRAFLUOROETHYLENE) WAS NOTED TO BE PEELING IN MULTIPLE AREAS. 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 15443725 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST PROCEDURE, PATIENT CAME WITH STROKE SYMPTOMS AND MRI CONFIRMED MICRO-BLEEDS IN THE BRAIN. PATIENT WAS HOSPITALIZED AND NEEDED MEDICATION TO RETURN TO BASELINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Stroke/CVA

  MAUDE report 14038734 ↗
• InjuryFeb 3, 2022Fracture; Fracture

  IT WAS REPORTED THAT DUAL CATHETER TANIQUE WAS USED FOR DURAL-AVF (ARTERIOVENOUS FISTULA) INTRACRANIAL COIL EMBOLIZATION PROCEDURE IN PATIENT WITH VERY MEANDERING VASCULATURE. DURING THE PROCEDURE THE CATHETER IN WHICH THE COIL WAS INSERTED MIGRATED FROM THE TARGET SITE, THEREFORE AN ATTEMPT WAS MADE TO PLACE THE CATHETER TO ITS ORIGINAL POSITION WITH THE SUBJECT GUIDEWIRE. BUT AT THE TIP OF THE CATHETER, SUBJECT GUIDEWIRE KNUCKLE LIKE J SHAPED AND WHEN THE CATHETER WAS PUSHED FORWARD AS IT WAS, THE GUIDEWIRE KINKED AT THE TIP OF THE CATHETER. WHEN AN ATTEMPT WAS MADE TO REMOVE THE GUIDEWIRE, THE SUBJECT GUIDEWIRE WAS RUPTURED AT THE KINKED PART, AND THE TIP OF THE SUBJECT GUIDEWIRE (ABOUT 3 CM) WAS LEFT INSIDE THE ANEURYSM WHERE COIL EMBOLIZATION WAS PERFORMED AND IT WAS PUSHED IN COIL MASS. THE SURGEON COMMENTED THAT IT WAS NOT A PROBLEM WITH THE DEVICE BUT A PROBLEM WITH THE WAY IT WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13435046 ↗
• MalfunctionOct 22, 2021Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING WAS PEELED IN SEVERAL LOCATIONS TO THE PROXIMAL END OF THE SUBJECT GUIDEWIRE. 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 12686558 ↗