Synchro SELECT SSFT215PRERecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613327508598), received between Jan 11, 2022 and Oct 16, 2025 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (12 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT GUIDEWIRE WAS FLUSHED AND NO DAMAGE WAS OBSERVED. NEXT, THE OPERATOR ADVANCED THE SUBJECT GUIDEWIRE THROUGH THE MICROCATHETER, HOWEVER, THE SUBJECT GUIDEWIRE DID NOT RESPOND TO THE TORQUE. THE OPERATOR REMOVED IT FOR INSPECTION, AND A FRACTURE WAS NOTED AT THE DISTAL END OF THE SUBJECT 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 23318457 ↗
• MalfunctionOct 3, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, DURING THE PROCEDURE AND WHILE OUTSIDE THE PATIENT, RESISTANCE WAS ENCOUNTERED AT THE HUB WHEN ATTEMPTING TO INSERT THE SUBJECT GUIDEWIRE INTO THE MICROCATHETER. UPON RETRIEVAL, THE SUBJECT GUIDEWIRE'S HYDROPHILIC COATING HAD ACCUMULATED AT ITS TIP. 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 23210036 ↗
• MalfunctionSep 25, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION, THE SUBJECT GUIDEWIRE COULD NOT BE INSERTED INTO THE MICROCATHETER. WHEN INSPECTED, SOME KIND OF COATING WAS SLID TO THE DISTAL TIP AND CURLED UP. 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 23151541 ↗
• MalfunctionMay 15, 2025Fracture; Fracture

  IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT GUIDEWIRE WAS REMOVED TO SHAPE THE DISTAL TIP, IT WAS FOUND TO BE FRACTURED FROM MID TO DISTAL SECTION. 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 22025410 ↗
• MalfunctionAug 13, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED DURING A VISIT TO CUSTOMER, THE DOCTOR REPORTED THAT THERE WAS AN INCIDENT IN WHICH THE COATING PEELED OFF ON A SUBJECT GUIDE WIRE USED IN THE EARLY STAGE OF THE PRODUCT LAUNCH. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19974072 ↗
• MalfunctionJun 26, 2024Peeled/Delaminated; Peeled/Delaminated

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE SUBJECT DEVICE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS NOTED TO BE PEELING. 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 19615650 ↗
• InjuryApr 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE OPERATOR ADVANCED THE SUBJECT GUIDEWIRE WITH THE MICROCATHETER TOWARDS THE INTRACEREBRAL OCCLUSION. HOWEVER, THE SUBJECT GUIDEWIRE LOOPED BACK. NEXT, THE OPERATOR BROUGHT THE MICROCATHETER TO OBTAIN MORE SUPPORT AND PULLED THE GUIDEWIRE BACK BUT THE TIP OF THE SUBJECT GUIDEWIRE HAS BROKEN OFF AND REMAINED IN THE VESSEL. THE SUBJECT GUIDEWIRE WAS REMOVED AND THE OPERATOR PROCEEDED TO REMOVE THE CLOTS. NEXT, THE OPERATOR USED THE STENT RETRIEVER TO REMOVE THE BROKEN TIP. THERE WAS A SURGICAL DELAY OF UNKNOWN LENGTH DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068556 ↗
• MalfunctionJul 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE SUBJECT GUIDEWIRE WITHIN A MICROCATHETER AND WHEN IT WAS RETRIEVED THE DISTAL OF THE SUBJECT GUIDEWIRE WAS FOUND TO BE BROKEN. 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 17360765 ↗
• InjuryApr 12, 2023Fracture; Unclear Information; Fracture; Unclear Information

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT GUIDEWIRE FRACTURED AND THE FRACTURED GUIDEWIRE CAUSED A RIGHT HEPATIC ARTERY DISSECTION. THE PHYSICIAN USED A SNARE TO REMOVE THE FRACTURED PART OF THE GUIDEWIRE AND FOUR COILS WERE DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 16723634 ↗
• MalfunctionMar 21, 2023Peeled/Delaminated; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELING. 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 16586706 ↗
• MalfunctionMar 13, 2023Peeled/Delaminated; 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 16534902 ↗
• MalfunctionJan 19, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE COATING AT THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) WAS PEELED OFF WHEN IT WAS BACK LOADED INTO THE INSERTER OUTSIDE OF 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 16210844 ↗
• MalfunctionJan 6, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION OF THE SUBJECT GUIDEWIRE, A SMALL SUBSTANCE, POTENTIALLY COATING FROM THE SUBJECT GUIDEWIRE, WAS OBSERVED. THE GUIDE WIRE WAS NOT IN CONTACT WITH THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16117441 ↗
• MalfunctionDec 2, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY WITH A HARD CLOT/STENOSIS PROXIMAL IN THE INTERNAL CAROTID ARTERY THE SUBJECT GUIDEWIRE WAS CROSSING THE THROMBUS WITH SOME FRICTION. AT WITHDRAWAL THE THE SUBJECT GUIDEWIRE TIP BROKE OFF, IT WAS CAPTURED IN THE PARTNERING CATHETER AND REMOVED WITHIN A FEW MINUTES (EST. 3-4MINUTES). 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 15904541 ↗
• InjuryOct 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING ENDOVASCULAR PROCEDURE IN A PATIENT WITH BASILAR ARTERY OCCLUSION, WHEN PHYSICIAN WAS ADVANCING FIRST GUIDEWIRE TO TARGET LESION, IT FRACTURED. PHYSICIAN THEN USED ANOTHER SECOND GUIDEWIRE(SUBJECT DEVICE) TO PLACE A RESCUE STENT TO ATTACH FIRST GUIDEWIRE ON THE WALL OF THE VESSEL, BUT SECOND GUIDEWIRE(SUBJECT DEVICE) ALSO FRACTURED. PHYSICIAN COMPLETED THE PROCEDURE BY ATTACHING BOTH THE FIRST AND SECOND(SUBJECT DEVICE) WIRES ON THE WALL WITH A STENT AS A MEDICAL INTERVENTION. FRAGMENT OF SECOND GUIDEWIRE(SUBJECT DEVICE) REMAINED INSIDE PATIENT'S ANATOMY. AFTER THE PROCEDURE, THE PATIENT HAD A MOTOR DEFICIT IN BOTH LIMBS. THE PATIENT'S SYMPTOMS RECOVERED, LIKE BEFORE THE PROCEDURE, AFTER 4 DAYS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Muscle Weakness/Atrophy

  MAUDE report 15655258 ↗
• InjuryOct 21, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING ENDOVASCULAR PROCEDURE IN A PATIENT WITH BASILAR ARTERY OCCLUSION, WHEN PHYSICIAN WAS ADVANCING FIRST GUIDEWIRE(SUBJECT DEVICE) TO TARGET LESION, IT FRACTURED. PHYSICIAN THEN USED ANOTHER SECOND GUIDEWIRE TO PLACE A RESCUE STENT TO ATTACH FIRST GUIDEWIRE(SUBJECT DEVICE) ON THE WALL OF THE VESSEL, BUT SECOND GUIDEWIRE ALSO FRACTURED. PHYSICIAN COMPLETED THE PROCEDURE BY ATTACHING BOTH THE FIRST(SUBJECT WIRE) AND SECOND WIRES ON THE WALL WITH A STENT AS A MEDICAL INTERVENTION. FRAGMENT OF FIRST GUIDEWIRE(SUBJECT DEVICE) REMAINED INSIDE PATIENT'S ANATOMY. AFTER THE PROCEDURE, THE PATIENT HAD A MOTOR DEFICIT IN BOTH LIMBS. THE PATIENT'S SYMPTOMS RECOVERED, LIKE BEFORE THE PROCEDURE, AFTER 4 DAYS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Muscle Weakness/Atrophy

  MAUDE report 15653994 ↗
• MalfunctionJun 3, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, WHEN THE SUBJECT GUIDEWIRE WAS USED TO GUIDE THE MICROCATHETER, THE HYDROPHILIC POLYMER COATING OF THE SUBJECT GUIDEWIRE WAS PEELED OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594277 ↗
• InjuryApr 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE ) BROKE. THERE HAD BEEN SOME WIRE RESHAPING DUE TO DIFFICULT ANATOMY. THERE WAS DIFFICULTY ADVANCING THE GUIDEWIRE (SUBJECT DEVICE) BUT IT WENT INTO THE ANEURYSM FOR THE MOST PART. ALSO, THERE WAS SOME RESISTANCE WHEN PULLING THE GUIDEWIRE (SUBJECT DEVICE) OUT OF THE ANEURYSM. POSSIBLE THAT THE GUIDEWIRE (SUBJECT DEVICE) HOOKED A LITTLE IN THE STENT. THEN THE DISTAL PART OF THE GUIDEWIRE (SUBJECT DEVICE) WAS LEFT IN THE MICROCATHETER AND THIS HAD TO BE PULLED OUT TO THE INTERMEDIATE CATHETER WITH THE GUIDEWIRE (SUBJECT DEVICE) AND A MEDICAL INTERVENTION WAS PERFORMED AS THIS HAD TO SECURE IT WITH A STENT RETRIEVER WHEN IT SEEMED TO DROP. 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 14069928 ↗
• MalfunctionMar 19, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED AFTER THE PROCEDURE WAS COMPLETED THE GUIDEWIRE (SUBJECT DEVICE) COATING WAS PEELING IN THE MIDDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827129 ↗
• MalfunctionJan 11, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN UNRUPTURED ANEURYSM ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, AFTER FLUSHING THE INTRODUCER SHEATH, WHEN THE SURGEON INSERTED AND PUSHED FORWARD THE SUBJECT GUIDEWIRE A LITTLE RESISTANCE WAS FELT IN THE MIDDLE. WHEN THE INTRODUCER SHEATH WAS ADVANCED TO THE END OF THE GUIDEWIRE, THE TIP OF THE INTRODUCER SHEATH WAS COVERED WITH A GREEN FIBROUS FOREIGN BODY. SO, THE SURGEON REPLACED THE SUBJECT GUIDEWIRE WITH A NEW DEVICE. 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 13232943 ↗
• MalfunctionJan 11, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING AN UNRUPTURED ANEURYSM ENDOVASCULAR COIL EMBOLIZATION PROCEDURE, AFTER FLUSHING THE INTRODUCER SHEATH, WHEN THE SURGEON INSERTED AND PUSHED FORWARD THE SUBJECT GUIDEWIRE A LITTLE RESISTANCE WAS FELT IN THE MIDDLE. WHEN THE INTRODUCER SHEATH WAS ADVANCED TO THE END OF THE GUIDEWIRE, THE TIP OF THE INTRODUCER SHEATH WAS COVERED WITH A GREEN FIBROUS FOREIGN BODY. 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 13232828 ↗