Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
FDA Recall Z-0347-2018 · Posted None
Recalling FirmStryker Neurovascular
Recall StatusTerminated
Product CodeNRY
Date Initiated2017-11-28
Date Terminated2020-04-28
Reason for Recall
Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
Firm Action
The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.
Root Cause
Packaging process control
Distribution Pattern
OUS only - NL, FR, IT, DE, BE
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.