FDA MedWatch: Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation

FDA MedWatch

Implantable Port Recall: Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

KCER Release Date: March 20, 2025

To: KCER Distribution list- including ESRD Network EDs and QIDs

March 20, 2025

Affected Product

What to Do

Do not use ProPort Implantable Plastic Port from affected lots.
Monitor patients who already have implanted ProPort Implantable Ports for signs of any adverse events.

On February 13, 2025, Smiths Medical sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

For healthcare providers

Follow the Instructions for Use:
- Monitor patients who have an implanted ProPort Implantable Port for signs of any adverse events.
- Make sure the housing and reservoir feel secure and stable when palpating the portal.
Symptoms such as swelling, redness, or discomfort at the implant site may indicate leakage or system failure.

For customers/distributors

Stop use and distribution of affected product.
Check inventory and quarantine all affected product.
Return all affected product.
Inform product users of the notification.
Complete and return the response form attached to the letter to smithsmedical8171@sedgwick.com within 10 days of receipt, even if you do not have the affected product and/or product has already been used.
If product was distributed to other facilities, notify anyone who may have received the product.
- Ask them to contact Sedgwick at 1-888-345-2656 to obtain a response form.

Reason for Recall

Smiths Medical is recalling ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate before, during, or after implantation.

The use of affected product may cause serious adverse health consequences, including complications from the delay or interruption of life-saving therapies, damage or scarring to skin or tissue surrounding the port from contact with leaking intravenous medications such as chemotherapy, air entering the bloodstream (air embolism), and death.

There have been two reported injuries. There have been no reports of death.

Device Use

ProPort Plastic Implantable Ports are part of a system for accessing veins (venous access) that includes the plastic port, a silicone or polyurethane catheter, a catheter connector, a Port-A-Cath access needle, a blunt needle, and a vein pick. ProPort systems are used when patient therapy requires repeated venous access for injections, infusions, and/or blood samples.

Contact Information

Customers in the U.S. with questions about this recall should contact Smiths Medical Customer Service at customerservice@icumed.com or 1-(800)-258-5361.

Full List of Affected Devices

Item Number	Item Description	UDI	Lot Number
21-4153-24	ProPort (Plastic standard portal) 1.9 mm PUR catheter – Kit	10610586012563	4453603
21-4155-24	ProPort (Plastic standard portal) 2.6 mm PUR catheter – Tray	10610586012594	4057817 4221725 3926119 3944833 3960347 3968098 3988451 4027913 4087000 4256939 4139520 4291484 4146467 4295931 4173474 4307473 4196758 4307474 4447572 4449876 4460619 6037144 6059285
21-4165-24	ProPort (Plastic standard portal) 2.6 mm PUR catheter. Pre- assembled – Tray	10610586012686	3984420 4235543 4242787 4294897
21-4171-24	ProPort (Plastic Low-Profile portal) 2.6 mm PUR catheter – Tray	10610586012716	3969275 4196768 4153873 4227788 4232310 4136364 4235600 3984421 3941279 4022601 4148590 4276227 4248718 4395512 4302980 4415445 4307478 4420760 4325880 4449877 4358053 4460620 4358054 6013083
21-4183-24	ProPort (Plastic Low-Profile portal) 1.9 mm PUR catheter – Tray	10610586012778	3916028 4256964 4163556 6026651 4235601 4221727 4248694 4256928
21-4187-24	ProPort (Plastic Low-Profile portal) 2.8 mm Silicone catheter – Tray	10610586012839	4196736 3922514

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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