The Recall Desk
SevereFDA (Devices)·Z-1277-2025·Announced 2025-03-26

Smiths Medical Plastic Venous Port May Separate Due to Manufacturing Defect

Smiths Medical is recalling ProPort Plastic Venous Access ports because the plastic housing may separate from the reservoir due to a manufacturing defect. Patients with these devices should contact their healthcare provider.

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, which establishes a minimum severity score of 4. The manufacturing defect could compromise the function of an implantable medical device, posing patient safety risk.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Venous Access System (REF 21-4150-24). This device provides intravenous access for patients requiring long-term medication or fluid administration.

The plastic port housing and port reservoir may separate due to a manufacturing defect. This defect could prevent the device from working as intended.

The recall affects 3 units with Lot Number 4235595 that were distributed worldwide.

Patients with these implanted devices or their healthcare providers should contact their healthcare provider immediately for further guidance on next steps.

The recalled product

Product
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Implantable Venous Access Port
Hazard
  • port-separation
  • 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 10610586012518
  • Lot Number 4235595

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category