Recall Z-0277-2018— Stryker Neurovascular
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: Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 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 060x132cm
- K143077 — Trevo XP ProVue Retriever (6X25mm)
- K132641 — MODIFIED TREVO PROVUE RETRIEVER
- K113778 — EXCELSIOR XT-27 MICROCATHETER
- K113260 — MODIFIED CONCENTIRC MICROCATHETER
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(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 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.