FDA recall Z-0347-2018

Product

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.

Distribution

OUS only - NL, FR, IT, DE, BE

Key facts

Status

Terminated

Initiation date

2017-11-28

Report date

2018-01-24

Termination date

2020-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2018