The Recall Desk
SevereFDA (Devices)·Z-1288-2025·Announced 2025-03-26

Smiths Medical ProPort Implantable Port Plastic Housing May Separate

The ProPort Low Profile Plastic Venous Access System is being recalled because the port housing and port reservoir may separate due to a manufacturing defect, affecting approximately 2,236 units distributed worldwide.

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 medical device recalls indicate a reasonable probability of serious adverse health consequences. Although no illnesses or deaths have been reported, the structural defect affecting an implanted vascular access device presents significant potential for harm.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Low Profile Plastic Venous Access System, an implantable medical device. The recall involves 2,236 units distributed worldwide.

The device is being recalled because the plastic port housing and port reservoir may separate due to a manufacturing defect. This separation could compromise the device's structural integrity and function.

The recall affects devices with the following lot numbers: 3906623, 3922514, 4120026, 4152690, 4157409, 4196736, 4227806, 4264408, 4271442, 4317086, 4337691, 4382350, 4387734, 4405011, 4440712, 4445592, 4460621, 4468591, 6013085, 6026683, 6037136, 6051319, 6071259. These devices are identified by UDI/DI 10610586012839.

This is classified as a Class I FDA recall. Patients and healthcare providers who have received one of the affected devices should contact Smiths Medical ASD, Inc. for further guidance and instructions.

The recalled product

Product
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Vascular Access System
Hazard
Affected units
2,236

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 10610586012839
  • Lot Numbers: 3906623
  • 3922514
  • 4120026
  • 4152690
  • 4157409
  • 4196736
  • 4227806
  • 4264408
  • 4271442
  • 4317086
  • 4337691
  • 4382350
  • 4387734
  • 4405011
  • 4440712
  • 4445592
  • 4460621
  • 4468591
  • 6013085

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 →

Related recalls

Same manufacturer · Smiths Medical ASD, Inc.

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Same hazard · structural defect

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