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.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2021%22
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