Skip to content
Recall Observatory FDA recall evidence

Device product

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001

Z-2800-2017

June 26, 2017

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 77671
Status
Terminated
Classification
Class II
Quantity
63 packs
Official record key
device-enforcement:Z-2800-2017

Official wording

Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.

Code information: Lot Numbers: QPC30107530, QPC30107745, QPC30107814, QPC30110247

Distribution pattern: nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.