Recall Z-0114-2021 ยท POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Stryker Neurovascular
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
| Date | Oct 21, 2020 (initiated Sep 21, 2020) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | On 09/21/2020, Urgent Medical Device Voluntary Recall - Removal notices were distributed to customers via courier. Risk Management/ Recall Coordinators/ Inventory Managers were asked to do the following: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to recalling firm. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform firm if any of the subjec |
| Quantity | 5365 |
| Distribution | U.S.: PA, OH, AK, NY, VA, IL, CA, NJ, AL, NV, FL, KY, AR, MA, TX, MI, NC, TN, WI, WA, AZ, OR, GA, VT, UT, DC, MO, IN, OK, NH, LA, HI, DE, SC, MS, RI, MD, SD, KS, ID, CO, CT, IA, NM, WV, MN, GU, NE. Foreign: New Zealand, Argentina, Estonia, Lithuania, Slovenia, Australia, Finland, Luxembourg, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190779 | Trevo XP ProVue Retriever Stryker, Jun 25, 2019 |