Synchro2Recalls & reported problems across all models

We found 4 models of Synchro2 by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 60 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2020 and Apr 6, 2026 — classified as 1 death, 25 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Fracture” (54 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Synchro2 recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Apr 18, 2024Class IIOpen, 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 · names 4 of these models · Recall details · FDA record ↗

Most reported Synchro2 problems

Synchro2 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Synchro2 S2SPS14215

  Wire, guide, catheter
  1 recall40 reports
• Synchro2 S2SPP14215

  Wire, guide, catheter
  1 recall12 reports
• Synchro2 S2SPS14300

  GUIDE, WIRE, CATHETER, NEUROVASCULATURE
  1 recall1 death6 reports
• Synchro2 S2SPP14300

  GUIDE, WIRE, CATHETER, NEUROVASCULATURE
  1 recall2 reports

Recent Synchro2 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Fracture; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS AND OBSERVED THAT THE DISTAL TIP OF THE SUBJECT DEVICE WAS DAMAGED, STRETCHED AND BROKEN/FRACTURED DURING USE. ALSO, THE PLOY TETRA FLUORO ETHYLENE (PTFE) COATING OF THE SUBJECT DEVICE WAS PEELING. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792780 ↗
• 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 ↗
• InjuryDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE SEVERE STENOSIS CASE OF MIDDLE CEREBRAL ARTERIES (MCA), THE PHYSICIAN USED THE SUBJECT GUIDEWIRE AND EXCHANGED IT TO PASS THROUGH THE LESION SITE AND REACH THE DISTAL END OF THE M2 SEGMENT. DURING THE PROCESS OF WITHDRAWAL, APPROXIMATELY 5 CM OF THE SUBJECT GUIDEWIRE'S TIP FRACTURED AT THE STENOSIS SITE. AFTERWARDS, THE PHYSICIAN USED A RETRIEVER STENT TO REMOVE THE SUBJECT GUIDEWIRE FRAGMENT AND CONCLUDED THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873591 ↗
• 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 ↗
• MalfunctionJan 3, 2025Fracture; Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE 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 21074243 ↗
• 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 ↗
• InjuryApr 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN AND REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19197260 ↗

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