Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
The Synchro SELECT 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 0.014in. 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. For lubricity, the distal portion of the device is coated with a hydrophilic polymer and the proximal portion of the guidewire is coated with polytetrafluoroethylene (PTFE). The torque device included with the guidewire attaches to the proximal end of the wire and functions as a steering guide. Rotation of this device facilitates guidewire placement into the appropriate vessel by precise directional manipulation of the guidewire tip. The introducer included with the guidewire is intended to aid insertion of the guidewire into the catheter hub and/or hemostasis valve.
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Catalog/UDI-DI/Lots: SSFT215PRE/07613327508598/0000139994, 0000144321, 0000146842, 0000154408; SSFT215STR/07613327508574/0000122897, 0000123151, 0000123405, 0000124931, 0000125040, 0000125719, 0000125720, 0000125787, 0000126356, 0000129220, 0000129221, 0000130861, 0000131723, 0000132954, 0000133179, 0000137045, 0000138580, 0000138581, 0000142280, 0000142281, 0000143349, 0000143584; SSFT300STR/07613327508581/0000144375, 0000155022; SSTD215PRE/07613327508512/0000122145, 0000122866, 0000127369, 0000139986, 0000140672, 0000141825, 0000141826, 0000143802, 0000146926, 0000149561, 0000154409, 0000154410, 0000154411, 0000176472; SSTD215STR/07613327508499/0000122481, 0000122485, 0000122650, 0000123069, 0000123070, 0000123143, 0000125409, 0000127494, 0000127495, 0000128254, 0000128446, 0000128447, 0000131661, 0000131667, 0000131668, 0000133396, 0000133563, 0000133564, 0000140971, 0000141392, 0000141393, 0000142532, 0000143125, 0000143209, 0000143806, 0000143834, 0000144140, 0000148427, 0000148428, 0000148477, 0000149560, 0000154679, 0000154680, 0000154681, 0000155021, 0000155662, 0000156792, 0000164588, 0000164589, 0000164591, 0000172898, 0000172899, 0000172900, 0000172911, 0000175987, 0000176018, 0000176019; SSTD300STR/07613327508505/0000145095, 0000145694, 0000151281; SSUP215PRE/07613327508635/0000144317, 0000148425; SSUP300PRE/07613327508642/0000145692, 0000151280; SSUP215STR/07613327508611/0000128253, 0000129625, 0000137050, 0000140671, 0000141784, 0000143342, 0000144318, 0000145693, 0000145875, 0000164662, 0000165477; SSUP300STR/07613327508628/0000121919, 0000141789, 0000145691
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
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 ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, INDIA, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, JORDAN, KUWAIT, LITHUANIA, LUXEMBOURG, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UAE, UK.
Recall record
- Recalling firm
- Stryker Neurovascular
- Product type
- Devices
- Recall number
- Z-1940-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Fremont, CA
- Recall initiated
- 2024-04-18
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1940-2024 · Source: openFDA enforcement.