The Recall Desk
SevereFDA (Devices)·Z-1281-2025·Announced 2025-03-26

Smiths Medical ProPort Implantable Port Risk of Component Separation

Smiths Medical is recalling its ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the port housing and reservoir to separate, potentially compromising device function.

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 mandates a minimum severity score of 4 per the rubric. No reported illnesses or injuries exist in the source; the Severe rating reflects the Class I designation and the potential for device malfunction in an implantable medical system.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate. This defect could compromise the device's function.

The affected product is a venous access system (implantable port) with UDI/DI 10610586012594. Approximately 3,263 units of the affected lot numbers have been distributed worldwide. Healthcare providers and patients using this device should be alert for potential separation of the port housing and reservoir components.

This is a Class I recall, indicating the most serious type of safety issue according to FDA classification standards.

The recalled product

Product
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
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Venous Access Port
Hazard
Affected units
3,263

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 (20)

  • UDI/DI 10610586012594
  • Lot Numbers: 3926119
  • 3928191
  • 3944833
  • 3960347
  • 3968098
  • 3988451
  • 4027913
  • 4057817
  • 4087000
  • 4139520
  • 4146467
  • 4173474
  • 4196758
  • 4221725
  • 4235599
  • 4256939
  • 4291484
  • 4295931
  • 4302979

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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