The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and p
Summary
The FDA issued a Class II for The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable by Stryker Neurovascular. Reason: Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practic.
Details
Source
Device Recall
External ID
Z-1940-2024
Action Date
2024-06-12
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: 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
Quantity Affected: 41,074
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 impacted product in their inventory are cautioned not to use this backloading technique.
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 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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-18
Company
Fremont, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 212 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Neurovascular) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Neurovascular have FDA actions?
Stryker Neurovascular has 26 FDA actions in our database, including 14 recalls and 12 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1940-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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