Stryker is recalling Wingspan Stent System (Rx Only, Sterile EO) due to reported use-related coating damage on delivery catheter shafts. Affected units have specific catalog numbers. No remedy is stated in the recall notice.
Use-related coating damage on delivery catheter shafts of Wingspan delivery catheters were reported
Stryker is recalling certain Wingspan Stent Systems for possible use-related coating damage on delivery catheters. This could affect medical procedures if the coating damage leads to improper function during use.
The recall reports that coating damage on delivery catheter shafts can occur during use. This damage might lead to improper device function during medical procedures, potentially affecting patient safety.
Medical professionals using the Wingspan Stent System for procedures are likely affected. Patients receiving this procedure may be at risk if the coating damage impacts device function.
Check for catalog numbers starting with M003WE followed by 0250090, 0300090, 0350090, 0400090, 0450090, 0250150, 0300150, 0350150, 0400150, 0450150, 0250200, 0300200, 0350200, 0400200, or 0450200. All lots of these products are affected.
Identify if your Wingspan Stent System has catalog numbers listed in the affected range.
The recall notice does not state any remedy.
Affected catalog numbers start with M003WE followed by 0250090, 0300090, 0350090, 0400090, 0450090, 0250150, 0300150, 0350150, 0400150, 0450150, 0250200, 0300200, 0350200, 0400200, or 0450200.
Check the catalog number on your device. If it starts with M003WE followed by the listed numbers, it is affected.
We’ve drafted a message you can send Stryker Neurovascular to request your refund or repair — edit it as you like.
Subject: Recall Z-3020-2018 — Stryker Neurovascular Stryker Neurovascular Hello, I own a Stryker Neurovascular that is covered by recall Z-3020-2018 from Stryker Neurovascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
