Recall Z-0347-2018— Stryker Neurovascular

Name: FDA recall Z-0347-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-28

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2017-11-28, terminated 2020-04-28. It names 2 FDA 510(k) clearances: K132641, K113260. Product: Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter. Reason: 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..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2017-11-28
Terminated: 2020-04-28
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K132641 — MODIFIED TREVO PROVUE RETRIEVERConcentric Medical, Inc.·cleared 2014-01-13
K113260 — MODIFIED CONCENTIRC MICROCATHETERConcentric Medical, Inc.·cleared 2012-03-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.