Synchro2 S2SPP14300Recalls & reported problems
Stryker Corporation · SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating · Class 2
All models of Synchro2 (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327459661), received between Dec 22, 2025 and Apr 6, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Fracture2
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, 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 ↗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 ↗
Other GUIDE, WIRE, CATHETER, NEUROVASCULATURE devices
- Synchro SELECT SSTD215STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall97 reports
- Synchro SELECT SSTD215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall16 reports
- Synchro SELECT SSUP215PREStryker Corporation · Guide, wire, catheter, neurovasculature1 recall11 reports
- Synchro2 S2SPS14300Stryker Corporation · GUIDE, WIRE, CATHETER, NEUROVASCULATURE1 recall1 death6 reports
- Synchro SELECT SSUP300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall5 reports
- Synchro SELECT SSFT300STRStryker Corporation · Guide, wire, catheter, neurovasculature1 recall0 reports
- Mirage 103-0608Micro Therapeutics, Inc. · Guide, wire, catheter, neurovasculature12 reports
- CHIKAI 008 WAIN-CKI-008-200Asahi Intecc CO., Ltd. · GUIDE, WIRE, CATHETER, NEUROVASCULATURE6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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