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Recall Observatory FDA recall evidence

Device product

Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.

Z-2598-2014

June 25, 2014

Class II

Product summary

Firm
Concentric Medical Inc
Event
Event 69119
Status
Terminated
Classification
Class II
Quantity
9 devices
Official record key
device-enforcement:Z-2598-2014

Official wording

Reason: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.

Code information: Model Number 90109; Lot number 35695

Distribution pattern: US Distribution including the states of PA, CA, TX, NM, and OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.