The FDA announced on June 8, 2018, that Stryker Neurovascular is recalling Synchro2 guidewires because product labels contain an incorrect millimeter dimension for the outer diameter. The agency classified the recall as Class II.
How to tell if you have it
- Brand: Stryker
- Product: Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating
- UPN Product No.: M00326010
- REF: 2601
- UPC: 04546540688729
- Lot Numbers: 0000000558, 0000000560, 0000000671, 0000000672, 0000000980, 0000000987, 0000001013, 0000001014, 0000001275, 0000001274, 0000001276, 0000001287, 0000001285, 0000001492, 0000001286, 0000001493, 0000001909, 0000001910, 0000002053, 0000002054, 0000002425, 0000002639, 0000002638, B47912, 0000002764, 0000002765, 0000003120, 0000003463, 0000003458, 0000003462, 0000003593, 0000003946, 0000003461, 0000003460, 0000003947, 0000003948, 0000003679, 0000004122, 0000004123, 0000004356, 0000004357, 0000004359, 0000004360, 0000004358, 0000004639, 0000004642, 0000004640, 0000004905, 0000004998, 0000005342, 0000005270, 0000005534, 0000005536, 0000005535, 0000005537, 0000005850, 0000005851, 0000006312, 0000006431, 0000006465, 0000006477, 0000006478, 0000006925, 0000006616, 0000006950, 0000006997, 0000007313, 0000007314, 0000007417, 0000007422
- Quantity: 13503
The hazard
According to the FDA, the product labels for the pouch and carton contain an incorrect value of 0.036mm for the Guidewire Outer Diameter dimension. The inches dimension of 0.014in on the label is correct, and the correct millimeter value should be 0.36mm. The agency described the error as a typographical mistake.
Context
GovInfoNow's records show Stryker Neurovascular has had 16 other recalls since June 26, 2017. Recent brand recalls include a premature battery drain risk for the INZONE Detachment System on April 6, 2026, and an IFU distribution error for the Trevo Trak 21 Microcatheter on Aug. 30, 2024. Other recent recalls of similar products include a Pipeline Flex Embolization Device recall with incorrect diameter labeling on June 25, 2026, and a Terumo Glidesheath Slender A-Kit recall involving wrong guidewire risk on June 15, 2026.