The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1282-2025·Announced 2025-03-26

Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect

Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 units distributed worldwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. While no deaths or illnesses have been reported, the manufacturing defect affecting a critical implanted venous access device presents a reasonable possibility of serious adverse health consequences.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System (REF 21-4165-24), a pre-assembled plastic implantable venous access system with a PolyFlow Polyurethane Catheter (2.6mm O.D. x 1.6mm I.D.) and 8.6Fr Introducer.

A manufacturing defect may cause the plastic port housing and port reservoir to separate. The recall affects 1,695 units distributed worldwide.

The affected lot numbers are: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, and 6003890.

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., 8.6Fr Introducer, REF 21-4165-24
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Venous Access
Hazard
Affected units
1,695

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 (16)

  • UDI/DI 10610586012686
  • Lot Numbers: 3918902
  • 3984420
  • 4079312
  • 4189868
  • 4221726
  • 4235543
  • 4242787
  • 4294897
  • 4307477
  • 4356314
  • 4364692
  • 4390226
  • 4445595
  • 4468593
  • 6003890.

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 12 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

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