Vital-Port Vascular Access System — Class II medical device recall Z-1223-2018
Terminated recall by Cook Vascular Inc., reported 2018-04-04. Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut or dislodge a
| Recall number | Z-1223-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Vascular Inc., Vandergrift, PA, United States |
| Recall initiated | 2017-11-28 |
| Classified | 2018-03-27 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2018-10-03 |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BM, BR, CA, CH, CN, CO, CR, CY, CZ, DE, DK, ES, FI, FR, GB, GT, HK, HU, ID, IE, IS, IT, JM, JO, JP, KE, KR, KW, LB, LV, MA, MX, NL, NZ, OM, PA, PL, PT, RS, SA, SE, SV, TR, TT, UA, UY, VE, ZA |
| Quantity | 31,006 units |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1223-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.