FDA Device recall Z-0114-2021
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM)
- FDA Device
- Class I
- terminated
- Published 2020-10-28
On 2020-10-28 the FDA classified a Class I recall of Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM) by Stryker Neurovascular, citing increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0114-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-09-21 |
| Published | 2020-10-28 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Neurovascular |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
Trevo XP ProVue Retriever, REF (Size): 90182 (4MM x 20MM); 90185 (4MM x 30MM); 90186 (6MM x 25MM). Procedure Pack REF: 80052, 93067, 93068, M0032PK42010001, M0033PK42022001, M0033PK43022001, M0033PK62523001, M0032PK42010002, M0032PK43010002, M0032PK62510002, M0033PK42022002, M0033PK43022002, M0033PK62523002
Reason
Increase in fracture complaints of the flexible, tapered core wire, resulting in stent retriever separation from the core wire during use. The stent retriever can be left behind in the vasculature.
Identifiers
| code_info | REF/Lots: 90182/ 0000030024, 0000030025, 0000030026, 0000030251, 0000030252, 0000030253, 0000030408, 0000030409, 000003…REF/Lots: 90182/ 0000030024, 0000030025, 0000030026, 0000030251, 0000030252, 0000030253, 0000030408, 0000030409, 0000030410, 0000030921, 0000030922, 0000030931, 0000031336, 0000031585, 0000031761, 0000031762, 0000031763, 0000032042, 0000032043, 0000032309, 0000032310, 0000032400, 0000032401, 0000032402, 0000032403, 30024, 30251, 30922, 31336, 31761, 31762; 90185/ 0000030030, 0000030031, 0000030260, 0000030261, 0000030407, 0000030415, 0000030416, 0000030924, 0000030925, 0000030926, 0000031338, 0000031588, 0000031764, 0000031765, 0000032040, 0000032041, 0000032313; 90186/ 0000030032, 0000030262, 0000030406, 0000030417, 0000030418, 0000030419, 0000030927, 0000030928, 0000030929, 0000030930, 0000031339, 0000031340, 0000031341, 0000031587, 0000032046, 0000032047; M0032PK42010002/ 38166585, 38191261, 38191264, 38449970, 38636576; M0032PK43010002/ 36967533, 36967572, 36967573, 36967574, 36967575, 36967576, 36967577, 36967578, 36967579, 36967580; 93067/ 60200184892, 60200184893, 6020018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Stryker Neurovascular
- INZONE DETACHMENT SYSTEM, REF: M00345100950
FDA Device · Class II · 2026-07-01 · Stryker Neurovascular - The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end a…
FDA Device · Class II · 2024-10-16 · Stryker Neurovascular - The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular - The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions
FDA Device · Class II · 2024-06-12 · Stryker Neurovascular
All Stryker Neurovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.