Synchro SELECT SSUP300PRERecalls & reported problems
Stryker Corporation · SUPPORT PRE-SHAPED Guidewire with Hydrophilic Coating · Class 2
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
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327508642), received between May 17, 2022 and May 22, 2023 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
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-1940-2024 · Root cause: Component design/selection · FDA record ↗
Most reported problems
Device problems
- Fracture2
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE, THE TIP OF THE SUBJECT GUIDEWIRE RIPPED OFF. THE BROKEN DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS RESCUED WITH THE SNARE DEVICE. PATIENT'S ANATOMY WAS MODERATELY 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 16974361 ↗InjuryMay 17, 2022Fracture; Fracture
IT WAS REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, PHYSICIAN FELT RESISTANCE IN THE DISTAL END WHILE OPERATING THE SUBJECT GUIDEWIRE. WHEN THE SUBJECT GUIDEWIRE WAS REMOVED TO INSERT THE COIL IT WAS CONFIRMED THAT THE 4CM TIP OF THE SUBJECT GUIDEWIRE WAS DETACHED AND LEFT INSIDE THE PATIENT'S ANATOMY. AN ATTEMPT WAS MADE TO RETRIEVE THE TIP BUT WAS DIFFICULT SO IT WAS EMBOLIZED WITH THE COILS. PATIENT'S ANATOMY WAS VERY MEANDERING. 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 14417784 ↗
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- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.