Table of contents
- Latest Smiths Medical ProPort Implantable Port Recall Updates
- March 19, 2025: FDA Posts Class I Recall
- February 13, 2025: Smiths Medical Sends Recall Letter
- Which Smiths Medical ProPort Implantable Ports Are Affected?
- Why Were the Smiths Medical ProPort Implantable Ports Recalled?
- Reported Incidents, Injuries, or Illnesses
- What Should Consumers Do?
- Legal Options
- Frequently Asked Questions
- Which Silicone ProPort Kits Are Included in the Recall?
- Who Can Provide the ProPort Recall Response Form?
- What Is the ProPort Implantable Port Used For?
- What Parts Make up the ProPort System?
Smiths Medical recalled its ProPort Plastic Implantable Ports because the plastic port housing and reservoir may separate. The FDA calls this a Class I recall, the most serious type.
The company sent an urgent recall letter on February 13, 2025. The FDA posted the recall on March 19, 2025, and the recall remains open.
Six ProPort Plastic items are named in the FDA table. Do not use affected lots, and report any problem to the FDA. No lawsuit, MDL or class action has been filed over this port.
Latest Smiths Medical ProPort Implantable Port Recall Updates
March 19, 2025: FDA Posts Class I Recall
The FDA posted a notice on March 19, 2025 for the recall of ProPort Plastic Implantable Ports. MedTech Dive reported the notice [1].
February 13, 2025: Smiths Medical Sends Recall Letter
Smiths Medical, now part of ICU Medical, sent all affected customers an Urgent Medical Device Recall letter dated February 13, 2025.
The California Department of Public Health lists the same recall date and the Class I rating on its recall sheet for the ProPort system [2].
Which Smiths Medical ProPort Implantable Ports Are Affected?
The FDA table names six ProPort Plastic items, each with its own item number and UDI:
- ProPort Plastic item 21-4153-24, a kit with a 1.9 mm polyurethane catheter, UDI 10610586012563
- ProPort Plastic item 21-4155-24, a tray with a 2.6 mm polyurethane catheter, UDI 10610586012594
- ProPort Plastic item 21-4165-24, a pre-assembled port system, UDI 10610586012686
- ProPort Plastic item 21-4171-24, a low-profile port with a 2.6 mm polyurethane catheter, UDI 10610586012716
- ProPort Plastic item 21-4183-24, a low-profile port with a 1.9 mm polyurethane catheter, UDI 10610586012778
- ProPort Plastic item 21-4187-24, a low-profile port with a 2.8 mm silicone catheter, UDI 10610586012839
California lists more ProPort Plastic Venous Access System references in the same recall: REF 21-4152-24, 21-4172-24, 21-4173-24 and 82-24, plus two silicone kits.
Why Were the Smiths Medical ProPort Implantable Ports Recalled?
Smiths Medical recalled the ports because of a manufacturing defect. The defect may cause the plastic port housing and port reservoir to separate. This may happen before, during, or after implantation.
The FDA says using affected product may cause serious harm. Possible harm includes delays in life-saving therapy. Leaking medicine, such as chemotherapy, may also damage or scar nearby skin or tissue.
The FDA also lists air entering the bloodstream, called air embolism, and death as possible results. The Oncology Nursing Society republished the FDA notice with the reason for the recall [3].
Reported Incidents, Injuries, or Illnesses
The FDA notice states that there have been two reported injuries and no reports of death. The notice does not say which injuries occurred or where they happened.
Reports like these do not prove the defect caused every problem a patient has with a port. They show what was reported to the company and the FDA at the time.
The FDA tells providers to watch for symptoms such as swelling, redness, or discomfort at the implant site. These may indicate leakage or system failure. Anyone with such symptoms should contact their care team.
What Should Consumers Do?
Follow these steps from the FDA notice if you have, use or supply a ProPort Plastic port:
- Do not use ProPort Plastic ports from the affected lots.
- Check your item numbers and lot numbers against the FDA table.
- Providers should monitor patients who already have implanted ProPort ports for signs of any adverse events.
- Customers and distributors should stop use and distribution, quarantine affected product and return it.
- Return the response form within 10 days of receipt, even if you have no affected product.
- Contact Smiths Medical Customer Service at customerservice@icumed.com or 1-800-258-5361.
- Report any problem to the FDA MedWatch program.
Legal Options
A recall does not automatically mean a person has a claim, and it does not decide who is responsible for a patient’s harm.
A person hurt by a recalled implanted port may ask about a device-injury review. Our page on the Bard PowerPort lawsuit covers a different implanted port.
Frequently Asked Questions
Which Silicone ProPort Kits Are Included in the Recall?
The silicone ProPort kits included in the recall are REF 21-4150-24 and 21-4151-24. Both are 8.4Fr silicone catheter kits listed with the other ProPort references on the California health department recall sheet.
Who Can Provide the ProPort Recall Response Form?
The ProPort recall response form can be requested from Sedgwick at 1-888-345-2656. The completed form goes to smithsmedical8171@sedgwick.com within 10 days of receipt, even if the customer has no affected product.
What Is the ProPort Implantable Port Used For?
The ProPort Plastic port is used when a patient’s therapy requires repeated venous access. Doctors use it for injections, infusions and blood samples, together with a catheter, an access needle and other parts of the system.
What Parts Make up the ProPort System?
The ProPort system parts, according to the FDA notice, are the plastic port, a silicone or polyurethane catheter, a catheter connector, a Port-A-Cath access needle, a blunt needle and a vein pick.