Recall Z-0275-2018— Stryker Neurovascular

Name: FDA recall Z-0275-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-03

Class II · Terminated

Class II FDA medical device recall by Stryker Neurovascular, initiated 2017-11-03, terminated 2019-11-04. It names 5 FDA 510(k) clearances: K151667, K143077, K132641 and 2 more. Product: Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit. 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..

Recalling firm: Stryker Neurovascular
Classification: Class II
Status: Terminated
Initiated: 2017-11-03
Terminated: 2019-11-04
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K151667 — AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cmStryker·cleared 2015-11-13
K143077 — Trevo XP ProVue Retriever (6X25mm)Concentric Medical, Inc.·cleared 2015-04-06
K132641 — MODIFIED TREVO PROVUE RETRIEVERConcentric Medical, Inc.·cleared 2014-01-13
K113778 — EXCELSIOR XT-27 MICROCATHETERStryker Neurovascular·cleared 2012-04-20
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

Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit

Reason for recall

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.

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