The Recall Desk
SevereFDA (Devices)·Z-1285-2025·Announced 2025-03-26

Smiths Medical ProPort Plastic Venous Access System Recalled for Port Housing Separation Risk

Smiths Medical is recalling certain ProPort Plastic Venous Access System devices due to a manufacturing defect that may cause the port housing and reservoir to separate.

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: FDA Class I classification establishes a minimum severity of Severe (4) per the rubric. No injuries or deaths are reported in the source text, so the classification does not qualify for Critical (5).

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports venous access system due to a manufacturing defect. The plastic port housing and port reservoir may separate.

The affected device is the ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter (reference number 21-4173-24, Lot Number 4317077). The recall involves 12 units that were distributed worldwide.

A separation of the port housing and reservoir could affect the proper function of the implanted device.

The recalled product

Product
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
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Ports
Hazard
  • port-separation
  • device-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 10610586012747
  • Lot Numbers: 4317077

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category