The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped version...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1940-2024.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1940-2024.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1940-2024.
Stryker Neurovascular
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Stryker Neurovascular Recall FAQ
Stryker Neurovascular is the subject of a surgical devices safety report: The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped version.... The notice was published on April 18, 2024 by the U.S. Food and Drug Administration (FDA). Approximately 41,074 units are potentially affected.