Source: US Department of Health and Human Services – 3
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.
Affected Product
Item Number
Product Name and Description
UDI
21-4153-24
ProPort (Plastic standard portal)
1.9 mm PUR catheter – Kit
10610586012563
21-4155-24
ProPort (Plastic standard portal)
2.6 mm PUR catheter – Tray
10610586012594
21-4165-24
ProPort (Plastic standard portal)
2.6 mm PUR catheter. Pre-assembled – Tray
10610586012686
21-4171-24
ProPort (Plastic Low-Profile portal)
2.6 mm PUR catheter – Tray
10610586012716
21-4183-24
ProPort (Plastic Low-Profile portal)
1.9 mm PUR catheter – Tray
10610586012778
21-4187-24
ProPort (Plastic Low-Profile portal)
2.8 mm Silicone catheter – Tray
10610586012839
Lots: See full list of affected devices below.
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
Table 1: Affected Products
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
40578174221725392611939448333960347396809839884514027913408700042569394139520429148441464674295931417347443074734196758430747444475724449876446061960371446059285
21-4165-24
ProPort (Plastic standard portal)2.6 mm PUR catheter. Pre-assembled – Tray
10610586012686
3984420423554342427874294897
21-4171-24
ProPort (Plastic Low-Profile portal)2.6 mm PUR catheter – Tray
10610586012716
396927541967684153873422778842323104136364423560039844213941279402260141485904276227424871843955124302980441544543074784420760432588044498774358053446062043580546013083
21-4183-24
ProPort (Plastic Low-Profile portal)1.9 mm PUR catheter – Tray
10610586012778
39160284256964416355660266514235601422172742486944256928
21-4187-24
ProPort (Plastic Low-Profile portal)2.8 mm Silicone catheter – Tray
10610586012839
41967363922514
Additional FDA Resources
FDA’s Enforcement Report
Smiths Medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Smiths Medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Smiths Medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Smiths Medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Smiths Medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4155-24
Smiths Medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
Smiths Medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4171-24
Smiths Medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
Smiths Medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer, REF 21-4173-24
Smiths Medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Smiths Medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-4183-24
Smiths Medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Medical Device Recall Database
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.
Content current as of:
03/19/2025
Regulated Product(s)