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Stryker Neurovascular FDA Recalls
15 recalls on file across devices, 0 of them Class I and 15 still open. Matched by name to SYK.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| INZONE DETACHMENT SYSTEM, REF: M00345100950Class IIApr 6, 2026Embolization coil detachment system devices may experience p |
| The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) Class IIAug 30, 2024Stryker Neurovascular has observed that devices with Out of |
| Trevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20, Catalog: 90183 Trevo XP ProVue RetrClass IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| DAC 044 115cm, Catalog: 90760Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| Trevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE, Catalog: 91412 TREVO NXT 4X28+Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| Trevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| Trevo ProVue, Catalog: 90184Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| Synchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm length, Catalog: M00313310 SYNCClass IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| Trevo Trak 21 Microcatheter, Catalog: 90338Class IIApr 23, 2024Neurovascular devices did not meet the minimum sample size r |
| The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pClass IIApr 18, 2024Stryker Neurovascular has observed an increased frequency of |
| The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro Class IIApr 18, 2024Stryker Neurovascular has observed an increased frequency of |
| The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shapClass IIApr 18, 2024Stryker Neurovascular has observed an increased frequency of |
| The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the dClass IIApr 3, 2024Stryker Neurovascular is recalling their DAC- Distal Access |
| Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACKClass IIJun 3, 2022Microcatheter product label on the carton is missing the mic |