Cook Vital-Port Recall Lawsuit | 2026 Latest Updates

Cook Vascular recalled part of its Vital-Port Vascular Access System, a device made by Cook Medical. The FDA recorded the action as a Class 2 device recall, effective March 27, 2018. Cook Vascular began the removal November 28, 2017. The action targeted a defect in the implantation needle, found in every non-expired Vital-Port lot. That defect could seriously injure patients during implant procedures. Providers holding recalled needles were told to stop using and return them to Cook Medical, and patients with an implanted Vital-Port can ask their provider if a recalled lot was used. The recall is Terminated, closed October 3, 2018.

Latest Cook Vital-Port Recall Updates

October 3, 2018: FDA Recall Record Updated to Terminated

The FDA recall record for the Vital-Port Vascular Access System changed status to Terminated on October 3, 2018. That closed the case the FDA had classified in March 2018. The recall covered the implantation needle only. Cook Vascular Inc. had started the removal in November 2017 over its non-coring needle. The agency tracked it under Recall Number Z-1223-2018 and Event ID 79425, the same identifiers its record still carries today.

March 27, 2018: FDA Classifies Action as Class 2 Device Recall

The FDA formally logged this removal under that classification on March 27, 2018, several months after Cook Vascular first initiated it. The agency assigned it recall number Z-1223-2018. This classification covered Cook Vascular Inc.’s removal of the Vital-Port’s non-coring implantation needle, which the company had already begun. The FDA record lists Cook Vascular Inc. as the recalling firm. The classification did not change the scope of the recall.

November 28, 2017: Cook Vascular Inc. Initiates the Removal

Cook Vascular Inc. initiated the removal on November 28, 2017, covering all non-expired lots of the Vital-Port Vascular Access System. The company acted after finding a defect in the device’s non-coring implantation needle. The needle’s defect risked harm to patients during implant procedures. Cook Vascular mailed written recall communication letters to its U.S. consignees to begin the removal process, per the FDA’s recall record.

September 30, 2008: FDA Clears the Vital-Port Power Injectable Port

The FDA cleared the Vital-Port Vascular Access System Power Injectable Port for market on September 30, 2008 [1]. Cook Vascular, Inc. filed the clearance under premarket notification 510(k) K081425. This clearance predates the 2017 recall by nearly a decade, well before the needle defect was found. The clearance record lists Cook Vascular, Inc. as the sole applicant for the device.

Which Cook Vital-Port Devices Are Affected?

The recall covers the non-coring implantation needle used with the Cook Vital-Port Vascular Access System, made by Cook Vascular Inc. It covers every non-expired lot, listed below:

• The non-coring implantation needle used at initial implant, under Product Code LJT [2]
• All non-expired lots of that needle, identified by the Code Information (IPI and P-S codes) on the package
• Devices originally cleared for market under FDA notification 510(k) K081425, filed in 2008

Vital-Port devices already placed in patients are not part of this recall. The recall targets only unused needle stock still held by providers and distributors. Providers and distributors can compare their on-hand stock against the FDA recall record to confirm whether they hold a recalled needle. That record lists 31,006 affected units.

Why Was the Cook Vital-Port Recalled?

Cook Vascular Inc. recalled the Vital-Port Vascular Access System because its non-coring implantation needle could cut or dislodge a piece of septum material. That fragment could then embolize, or travel through the bloodstream. The defect could also let medication or fluid leak at the implant site. The FDA determined the cause was a nonconforming material or component in the needle. Cook Vascular documented this in its recall record, Number Z-1223-2018. The recalled needle is used only before or during the initial implant procedure, not for any later access to the port, so it does not affect devices already in place.

Reported Incidents, Injuries, or Illnesses

The FDA’s Class 2 device recall record does not list a count of reported incidents, injuries, or deaths for the Vital-Port. The agency’s recall record covers only the product, the defect, and the removal action. The needle’s defect drove Cook Vascular’s decision to recall it. No adverse-event count triggered the action. An absent count is not evidence that no incidents occurred. Cook Vascular’s adverse-event filings for this device could not be reviewed as part of this recall’s public record. Reports of harm are not proof that a product caused every incident. Anyone who believes they were harmed by a Vital-Port device can report it to the FDA and to Cook Medical directly.

What Should Consumers Do?

Anyone connected to the Cook Vital-Port recall should take the following steps:

1. Ask your implanting provider whether the needle used during your Vital-Port placement came from a recalled lot.
2. Know that a port already in place does not need removal or replacement because of this recall alone.
3. If you are a provider or distributor holding recalled non-coring needles, stop using them immediately.
4. Return any recalled needles you hold to Cook’s regional distribution warehouse for destruction.
5. Contact Cook Medical Customer Relations at 812-339-2235 with any questions about the recall.
6. Watch for any recall updates or further guidance posted to the FDA’s recall record.

Legal Options

A recall does not automatically establish liability or eligibility for compensation. Schmidt & Clark reviews product-liability and device-defect claims. This includes claims involving ports like the Vital-Port and similar port catheter lawsuit claims. No Vital-Port lawsuit or MDL has been filed yet. Only a lawyer can confirm if you may have a claim.

Frequently Asked Questions

What Type of Medical Device Is the Vital-Port?

The Vital-Port is a type of medical device: an implanted, subcutaneous intravascular infusion port and catheter. The FDA regulates this device category under 21 CFR 880.5965, the same classification covering the Vital-Port’s non-coring needle, Product Code LJT.

What Is the Cook Vital-Port Vascular Access System Used For?

The Cook Vital-Port Vascular Access System is used for long-term vascular access in patient therapy. The FDA classifies it under the Port Catheter Implanted Subcutaneous device category, intended for infusion therapy and/or blood sampling.

What Is a Non-Coring Needle?

A non-coring needle is designed not to cut or core a plug of material when it punctures an implanted port. The FDA’s device record shows Cook Vascular’s related 510(k) application was received May 21, 2008. That was months before the design was cleared for market.

Who Manufactures the Cook Vital-Port and Where Is the Company Based?

Cook Vascular, Inc. manufactures the Vital-Port Vascular Access System and is based at 1186 Montgomery Ln. in Vandergrift, Pennsylvania, according to its FDA 510(k) filing for the device. Cook Vascular is part of Cook Medical.

What Event ID Did the FDA Assign to the Cook Vital-Port Recall?

The FDA assigned Event ID 79425 to the Cook Vital-Port recall. An Event ID identifies the overall recall case in the FDA’s system. A separate Recall Number classifies each specific action tied to that case, and both point to the same underlying record.

Can I File a Lawsuit over the Cook Vital-Port Recall?

No lawsuit, class action, or MDL has been filed specifically over the Cook Vital-Port. Schmidt & Clark reviews device-defect and product-liability claims involving vascular access ports like it. Only an individual legal review can confirm whether a claim may be pursued.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K081425
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=LJT