The Recall Desk
ModerateFDA (Devices)·Z-2800-2017·Announced 2017-08-09

Stryker Neurovascular Recalls Stroke Fast Packs Due to Labeling Mismatch

Stryker Neurovascular is recalling 63 Stroke Fast Packs because the printed carton contents did not match the physical items inside.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling/packaging mismatch without reported injuries or illnesses, fitting the criteria for minor labeling errors or low-risk issues.

Plain-English summary

Stryker Neurovascular is recalling 63 Stroke Fast Packs (Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM) distributed nationwide. The recall was initiated because the pre-printed contents on the back of the carton sleeve did not match the physical contents of the pack.

The affected products are identified by the following lot numbers: QPC30107530, QPC30107745, QPC30107814, and QPC30110247. The agency has classified this as a Class II recall.

Healthcare providers and facilities should stop using the affected packs and contact Stryker Neurovascular for instructions on return or replacement. This recall addresses a packaging and labeling discrepancy rather than a defect in the medical devices themselves.

The recalled product

Product
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Affected units
63

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot Numbers: QPC30107530
  • QPC30107745
  • QPC30107814
  • QPC30110247

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Stryker Neurovascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →