Cook Vital-Port Vascular Access System Recall for Needle-Related Septum Damage
Cook Vascular Inc. is recalling Vital-Port Vascular Access Systems because the included non-coring needle may cut or dislodge material from the device septum during initial implant.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (material dislodgement) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Vascular Inc. is recalling 31,006 units of the Vital-Port Vascular Access System, a subcutaneous, implanted, intravascular infusion port and catheter. The recall involves the non-coring needle provided with the device, which may cut or dislodge a core or sliver of material from the Vital-Port septum when inserted during the initial implant procedure.
The recall does not impact Vital-Port products that have been successfully placed in patients. The devices were distributed within the United States and numerous international countries, including Canada, the United Kingdom, Germany, and Australia.
Healthcare providers and patients should contact Cook Vascular Inc. for further instructions regarding the recall and potential replacement of the affected needles or devices.
The recalled product
- 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.
- Manufacturer
- Cook Vascular Inc.
- Category
- Medical Device — Vascular Access
- Affected units
- 31,006
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 (2)
- IPI
- P-S
Distribution
Distributed in 1 state:
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