The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are… Recall
Issued June 12, 2024 · Stryker Neurovascular
In June 2024, Stryker Neurovascular recalled the The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Stryker Neurovascular to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Recall details
- Brand
- Stryker Neurovascular
- Category
- Health
- Recall date
- June 12, 2024
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-1941-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Stryker Neurovascular has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.