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Recall Observatory FDA recall evidence

Device product

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

Z-0347-2018

November 28, 2017

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 78716
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0347-2018

Official wording

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.

Code information: UPN/Model No. 80052; Lot 63034

Distribution pattern: OUS only - NL, FR, IT, DE, BE

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.