Stryker Neurovascular recalls
6 official recalls and safety alerts involving Stryker Neurovascular since 2022-07, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Stryker Neurovascular or the relevant agency.
- 2026-07-01
USStryker Neurovascular recalls INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended,…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of PA, AZ, FL,…Official notice →- 2024-10-16
- US
Stryker Neurovascular recalls The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end…
Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configurations, have been erroneously distributed…
FDA · DeviceStryker NeurovascularU.S. Nationwide distribution in the states of CA and VA.Official notice → - 2024-06-12
- US
Stryker Neurovascular recalls The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The…
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…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of TX, NY, MD,…Official notice → - 2024-06-05
- US
Stryker Neurovascular recalls Trevo ProVue, Catalog: 90184
Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may exceed the acceptable…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of MN, PA, IL,…Official notice → - 2024-05-08
- US
Stryker Neurovascular recalls The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker on the distal end and a…
Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. The reason for the recall is: the DAC Lot #0000486382 was released with out-of-specification…
FDA · DeviceStryker NeurovascularUS Nationwide distribution in the states of TX, FL, NJ, CO, LA, NC, AL, PA,…Official notice → - 2022-07-27
- US
Stryker Neurovascular recalls Trevo Trak 21 Microcatheter, REF: 90338. TREVO NXT 3X32+TRAK21 2-PACK - CE, REF: 91412; TREVO NXT 4X28+TRAK21 2-PACK - CE, REF: 91413;…
Microcatheter product label on the carton is missing the microcatheter product drawing/illustration.
FDA · DeviceStryker NeurovascularWorldwide distribution - US Nationwide distribution in the states of CA, OR,…Official notice →