Stryker Neurovascular Recall: The Synchro2 Guidewires are a steerable guidewire family wit
Stryker Neurovascular Recall: The Synchro2 Guidewires are a steerable guidewire family wit is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Stryker Neurovascular; Product: The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre
| Recalling firm | Stryker Neurovascular |
|---|---|
| Product | The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewires are compatible with existing microcatheters used in common procedures such as those used in endovascular diagnosis and therapy of neurovascular disease. The distal portion of the guidewire tip is radiopaque. |
| Reason for recall | 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 im |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Worldwide - US Nationwide distribution including in the states of TX, NY, MD, CA, KY, WI, OR, NE, SC, MA, MO, CT, ID, PA, TN, FL, NC, AL, IA, OK, VA, IL, OH, NH, MN, ND, KS, NJ, WV, IN, GA, HI, AR, UT, LA, MI, WA, NV, CO, AZ, DC, VT, ME, DE, AK, WY, MT, NM, SD, MS, RI, GU and the countries of ARGENT |
| Recall initiated | 20240418 |
| Recall number | Z-1941-2024 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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