Recall Z-0276-2018 ยท NRY Catheter, Thrombus Retriever
Stryker Neurovascular
Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 Stroke intervention kit
| Date | Dec 5, 2017 (initiated Nov 3, 2017) |
| Status | Terminated |
| Reason | Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack. |
| Root cause | Labeling Change Control |
| Action | The firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your |
| Quantity | 2 units |
| Distribution | International Distribution to: Germany, Slovakia and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113260 | MODIFIED CONCENTIRC MICROCATHETER Concentric Medical, Inc., Mar 9, 2012 |
| K113778 | EXCELSIOR XT-27 MICROCATHETER Stryker Neurovascular, Apr 20, 2012 |
| K132641 | MODIFIED TREVO PROVUE RETRIEVER Concentric Medical, Inc., Jan 13, 2014 |
| K143077 | Trevo XP ProVue Retriever (6X25mm) Concentric Medical, Inc., Apr 6, 2015 |
| K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Stryker, Nov 13, 2015 |