FDANovember 28, 2017device

Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular infusion port and catheter, IP, IP-S, Product usage: The devices are intended for use in patient therapy requiring long-term vascular access for infusion therapy and/or blood sampling.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a core or sliver of material from the Vital-Port septum when the non-coring needle is inserted into the Vital-Port. This needle is used on the initial implant of the Vital-Port. Vital-Port products that have been successfully placed in patients are not impacted by this recall.

What to do

FDA enforcement status: Terminated

Brands named

cook vascularcook

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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