Synchro2 S2SPS14215Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 07613327459630), received between Feb 7, 2020 and Feb 17, 2026 — classified as 15 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Fracture” (35 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-1941-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2026Fracture

  IT WAS REPORTED THAT PHYSICIAN FOUND TIP OF SUBJECT GUIDEWIRE STRETCHED AND AT A CERTAIN POINT THE SUBJECT GUIDEWIRE APPEARED TO NO LONGER RESPOND TO TORQUE CONTROL. THE OPERATOR ATTEMPTED TO REMOVE THE GUIDEWIRE TO REPLACE IT, BUT IT WAS BROKEN AND A PORTION REMAINED INSIDE THE VESSEL. SO, IT WAS REMOVED USING A RETRIEVER AND PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361528 ↗
• InjuryNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE, THE DISTAL END OF THE SUBJECT GUIDEWIRE GOT BROKE INSIDE THE PATIENT WHICH WAS REMOVED WITH THE HELP OF 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 23659980 ↗
• MalfunctionNov 21, 2025Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. 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 23621797 ↗
• MalfunctionJul 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE BROKE OFF DURING AN INTERVENTION AFTER PROBING DURING RETRACTION. 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 22577110 ↗
• MalfunctionApr 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE THERE WAS RESISTANCE FELT WHEN MANIPULATING THE SUBJECT GUIDEWIRE (WASN¿T MOVING SMOOTHLY), AND JUST AS STENT WAS ADVANCED CLOSE TO LESION THE SUBJECT GUIDEWIRE BECAME STUCK. UPON ATTEMPTING TO REMOVE THE SUBJECT GUIDEWIRE, MORE RESISTANCE WAS FELT UNTIL THE SUBJECT GUIDEWIRE FELT LIKE IT ¿BROKE FREE¿ OF WHATEVER WAS CAUSING THE RESISTANCE. WHEN THE SUBJECT GUIDEWIRE WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED TO BE ¿FRACTURED AND STRETCHED¿ AT THE DISTAL END. 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 21816441 ↗
• MalfunctionFeb 21, 2025Fracture; Fracture

  THE GUIDEWIRE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED 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 21433259 ↗
• MalfunctionDec 10, 2024Fracture; Fracture

  ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE DEVICE REVEALED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE HAD BEEN FRACTURED AND SEPARATED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893340 ↗
• MalfunctionOct 4, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE FOR AN ACUTE ISCHEMIC STROKE PATIENT WITH A CALCIFIED CLOT LOCATED AT M1, THE PHYSICIAN FACED RESISTANCE WHEN ADVANCING THE SUBJECT GUIDEWIRE HALFWAY THROUGH THE CLOT. WHILE ADVANCING, THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS UNABLE TO TORQUE PROPERLY AND GOT LODGED IN THE CLOT AREA. WHEN THE SUBJECT GUIDEWIRE WAS REMOVED FROM THE MICROCATHETER, THE PHYSICIAN OBSERVED THAT THE DISTAL TIP WAS STRETCHED PARTIALLY BROKEN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20371734 ↗
• MalfunctionSep 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT SUBJECT GUIDEWIRE BROKEN INSIDE THE PATIENT AFTER A LOT OF MANUAL MANIPULATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157240 ↗
• MalfunctionMay 21, 2024Fracture; Fracture

  IT WAS DURING THE PROCEDURE, THE SUBJECT GUIDEWIRE WAS TORN APPROXIMATELY IN THE DISTAL TO MIDDLE THIRD DURING AN INTERVENTION IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED AS NO CLINICAL CONSEQUENCE TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19366799 ↗
• MalfunctionMay 10, 2024Fracture; Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF THE GUIDEWIRE (SUBJECT DEVICE) WAS FRACTURED DURING USE. 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 19292581 ↗
• MalfunctionJan 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN REMOVED THE SUBJECT GUIDEWIRE FROM THE DISPENSER HOOP AND SHAPED IT. DURING THE DELIVERY OF THE SUBJECT GUIDEWIRE THE PHYSICIAN FOUND THAT THE MIDDLE PART OF THE SUBJECT GUIDEWIRE WAS KINKED AND THE AREA AROUND KINK WAS EXPOSED AND HAD NO PTFE (POLYTETRAFLUOROETHYLENE) COATING. 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 18588471 ↗
• MalfunctionDec 14, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT COATING OF THE GUIDEWIRE (SUBJECT DEVICE) STRIPPED OFF INTO SCRUB NURSE'S HAND BEFORE WIRE WAS INTRODUCED TO CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18327658 ↗
• MalfunctionNov 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING MIDDLE CEREBRAL ARTERY (MCA) STENOSIS PROCEDURE, THE OPERATOR USED THE SUBJECT GUIDEWIRE TO DELIVER THE MICROCATHETER. HOWEVER, AFTER SUPER SELECTING THE OPERATOR FELT THE SUBJECT GUIDEWIRE FRACTURED SO HE TOOK IT OUT AND CONFIRMED IT WAS 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 18070422 ↗
• MalfunctionOct 3, 2023Fracture; Fracture

  THE DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION OF THE DEVICE REVEALED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17858568 ↗
• InjuryAug 29, 2023Fracture; Peeled/Delaminated; Fracture; Peeled/Delaminated

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE PTFE COATING OF THE SUBJECT GUIDEWIRE WAS PEELED, AND THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. 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 17647456 ↗
• InjuryAug 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING PROCEDURE WHEN THE SURGEON PULLED OUT THE GUIDEWIRE (SUBJECT DEVICE) ON THE PROXIMAL ICA (INTERNAL CAROTID ARTERY) AFTER LT. ICA THROMBECTOMY, THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF. THE GUIDEWIRE (SUBJECT DEVICE) WAS LOOPING STATE WHEN THE SURGEON TRIED TO PULL IT OUT. THE BROKEN (SUBJECT DEVICE) FRAGMENT REMAINS IN PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17545552 ↗
• InjuryJul 17, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE OF STROKE WITH A HUGE INFRACTION, THE SUBJECT GUIDEWIRE WAS TORN INTO TWO SEGMENTS INSIDE THE BALLOON GUIDE CATHETER WHEN GOING UP WITH THE INTERMEDIATE CATHETER PROXIMAL TO THE TORTUOUS PART. THE PHYSICIAN USED A SNARE DEVICE TO PULL OUT THE TORN SEGMENT. THE PATIENT'S ANATOMY WAS TORTUOUS. 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 17331485 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE ACUTE THROMBECTOMY PROCEDURE, THE PHYSICIAN COULD NOT ROTATE THE GUIDEWIRE (SUBJECT DEVICE) AND ENCOUNTERED FRICTION ADVANCING THE GUIDEWIRE (SUBJECT DEVICE) WITHIN THE MICROCATHETER. UPON REMOVAL OF THE GUIDEWIRE (SUBJECT DEVICE) IT WAS FOUND TO BE FRACTURED 4CM FROM THE DISTAL END. THE PHYSICIAN REPLACED THE GUIDEWIRE WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930845 ↗
• InjuryMay 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THROMBECTOMY PROCEDURE IN A PATIENT WITH LEFT MIDDLE CEREBRAL ARTERY MCA M1ACUTE CEREBRAL INFARCTION, THE SUBJECT GUIDEWIRE WAS NOT ABLE TO BE ADVANCED PASS THE OCCLUSION TO REACH THE DISTAL. THE OPERATOR WITHDREW THE GUIDEWIRE AND FELT THE TRACTION FORCE AT PROXIMAL OF THE GUIDEWIRE SPRING BACK BUT COULD BE REMOVED OUT SLOWLY. THE DISTAL SOFT SEGMENT COULD BE DEVELOPED BUT COULD NOT REACT TO THE MANIPULATION. THE OPERATOR THOUGHT THE GUIDEWIRE MIGHT BE FRACTURED SO USED OTHER GUIDEWIRE TO MAKE LOOP TO WORK TOGETHER WITH MICROCATHETER TO TAKE THE FRACTURED SUBJECT GUIDEWIRE OUT. THE OPERATOR THEN DECIDED TO REARRANGE ANOTHER SURGERY BECAUSE THE PATIENT HAD IN SITU THROMBUS WITH CHRONIC OCCLUSION STENOSIS. THE PATIENT WAS DISCHARGED WITHOUT ANY CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16898772 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE PERFORMING A DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) PATIENT SUFFERED STROKE, A NON OCCLUSIVE THROMBUS IN THE RIGHT DISTAL ACA TERRITORY AND MCA INFERIOR DIVISION WAS NOTICED. PATIENT WAS ADMINISTERED 2 MG TPA X 2 AND 2 MG INTEGRELLIN INJECTED IN THE A3 SEGMENT, AND 2 MG OF INTEGRELLIN INJECTED IN THE INFERIOR DIVISION OF MCA M4 SEGMENT WITH IMPROVEMENT SEEN OF DISTAL FLOW. IT WAS INDICATED THAT THE STROKE HAD CAUSAL RELATIONSHIP WITH THE STUDY PROCEDURE, AND HAS A POSSIBLE RELATIONSHIP WITH TO DAPT, OTHER STRYKER DEVICES (INCLUDING THE SUBJECT GUIDEWIRE) AND AN UNDERLYING CONDITION OR DISEASE. IT WAS NOTED THAT THE OUTCOME OF THE STROKE WAS RECOVERED/RESOLVED ON (B)(6) 2023. ON THE SAME DAY, POST PROCEDURE, PATIENT WAS EXTUBATED WITH CONCERN FOR NEW STROKE, TAKEN FOR CT HEAD, AT WHICH TIME SHE BECAME UNRESPONSIVE AND HYPOTENSIVE, REQUIRED INTUBATED, EMERGENT CTA ABD/PELVIS REVELING ACTIVE EXTRAVASATION FROM THE R CFA WITH ASSOCIATED HEMATOMA (RETROPERITONEAL HEMORRHAGE). PATIENT WAS TRANSFERRED EMERGENTLY TO NSICU AND VASCULAR SURGERY WAS CANCELLED. PATIENT INITIALLY REQUIRED PHENYLEPINEPHRINE 100 MCG/MIN, WHICH WAS DECREASED AND EVENTUALLY

  Patient problems: Multiple Organ Dysfunction Syndrome; Retroperitoneal Hemorrhage; Stroke/CVA

  MAUDE report 16791588 ↗
• MalfunctionFeb 28, 2023Fracture; Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND IT WAS DISCOVERED THAT THE GUIDEWIRE (SUBJECT DEVICE) DISTAL TIP-WAS BROKEN/FRACTURED DURING USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 16454500 ↗
• InjuryJan 31, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN PROBING OF THE A CEREBRI MEDIA VIA A MICROCATHETER, THE SUBJECT GUIDEWIRE DISTAL END WAS RUPTURED INCLUDING "RAVELING" WITH ENDOVASCULAR FOREIGN BODY LOSS AND CONSECUTIVE DIFFICULT RETRACTION OCCURRED. NO CLINICAL CONSEQUENCES WERE REPORTED . NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272521 ↗
• InjuryNov 11, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE FRACTURED DURING USE AND THEREFORE A SNARE WAS USED TO RETRIEVE THE FRACTURED SUBJECT GUIDEWIRE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15785326 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR M2 THROMBECTOMY PROCEDURE IN A PATIENT, THE SUBJECT GUIDEWIRE TIP BROKE AT M1 INSIDE THE PATIENT. THE BROKEN FRAGMENT WAS REMOVED FROM THE PATIENT'S ANATOMY BY PULLING IT. THERE WAS A SURGICAL DELAY OF 10 MINUTES DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT EITHER DUE TO THE REPORTED ISSUE OR DUE TO THE SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15678029 ↗