The Recall Desk
SevereFDA (Devices)·Z-1286-2025·Announced 2025-03-26

Smiths Medical ProPort Implantable Port May Separate Due to Manufacturing Defect

Smiths Medical is recalling ProPort Plastic Venous Access Ports because the port housing and reservoir may separate due to a manufacturing defect. Contact your physician if you have an affected device.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall. The agency's classification establishes a minimum severity of 4. The manufacturing defect could cause component separation in an implanted medical device with direct access to the venous system, posing potential serious health consequences. No illnesses or injuries have been reported to date.

Plain-English summary

Smiths Medical ASD, Inc. has recalled the ProPort Plastic Implantable Venous Access System because the plastic port housing and port reservoir may separate due to a manufacturing defect.

The affected lot is 4196769. This device has been distributed worldwide.

Patients with the affected device should contact their physician or healthcare provider to discuss the situation and determine if replacement or other action is needed.

The FDA has classified this as a Class I recall.

The recalled product

Product
smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Venous Access
Hazard
  • device-malfunction
  • manufacturing-defect

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)

  • UDI/DI 10610586012754
  • Lot Numbers: 4196769

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category