Cook Vascular Inc.: Medical Device Recall in 2018 - (Recall #: Z-1223-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 28, 2017

Date Posted: April 4, 2018

Recall Number: Z-1223-2018

Event ID: 79425

Reason for Recall:

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.

Status: Terminated

Product Quantity: 31,006 Units

Code Information:

IPI, P-S

Distribution Pattern:

The devices have been distributed within the United States and the following countries: United Arab Emirates, Argentina, Austria, Australia, Barbados, Belgium, Bulgaria, Bermuda, Brazil, Canada, Switzerland, Colombia, Costa Rica, Cyprus, Czech Republic, Germany, Denmark, Spain, Finland, Faroe Islands, France, United Kingdom, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Iceland, Italy, Jamaica, Jordan, Japan, Kenya, South Korea, Kuwait, Lebanon, Latvia, Morocco, Macedonia, Mexico, Netherlands, New Zealand, Oman, Panama, Poland, Portugal, Serbia, Saudi Arabia, Sweden, San Marino, El Salvador, Turkey, Trinidad & Tobago, Ukraine, Uruguay, Venezuela, Virgin Islands, Kosovo, China, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated