Reported Jun 12, 2024 · Ongoing
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and…
Stryker Neurovascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Neurovascular · 47900 Bayside Pkwy · Fremont, CA · 94538-6515
Is this the product you have?
- 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 codes and dates
10 of 10 products
Products covered by this recall # Barcodes Product as published 1 07613327508598SSFT215PRE/07613327508598/0000139994, 0000144321, 0000146842, 0000154408 2 07613327508574SSFT215STR/07613327508574/0000122897, 0000123151, 0000123405, 0000124931, 0000125040, 0000125719, 0000125720, 0000125787, 0000126356, 0000129220, 0000129221, 0000130861, 0000131723, 0000132954, 0000133179, 0000137045, 0000138580, 0000138581, 0000142280, 0000142281, 0000143349, 0000143584 3 07613327508581SSFT300STR/07613327508581/0000144375, 0000155022 4 07613327508512SSTD215PRE/07613327508512/0000122145, 0000122866, 0000127369, 0000139986, 0000140672, 0000141825, 0000141826, 0000143802, 0000146926, 0000149561, 0000154409, 0000154410, 0000154411, 0000176472 5 07613327508499SSTD215STR/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 6 07613327508505SSTD300STR/07613327508505/0000145095, 0000145694, 0000151281 7 07613327508635SSUP215PRE/07613327508635/0000144317, 0000148425 8 07613327508642SSUP300PRE/07613327508642/0000145692, 0000151280 9 07613327508611SSUP215STR/07613327508611/0000128253, 0000129625, 0000137050, 0000140671, 0000141784, 0000143342, 0000144318, 0000145693, 0000145875, 0000164662, 0000165477 10 07613327508628SSUP300STR/07613327508628/0000121919, 0000141789, 0000145691 - Amount recalled
- 41,074
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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