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

Smiths Medical ProPort Plastic Venous Access System Recalled

Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic 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: The FDA has classified this as a Class I recall. Class I recalls indicate a serious health hazard. Although no reported illnesses or injuries are mentioned in the source text, the structural defect (separation of port housing and reservoir in an implantable venous access device) represents a significant risk of harm, meeting the Severe threshold.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports (Silicone Catheter, 2.87 O.D., 8.4Fr, 1.0mm I.D., REF 21-4150-24) due to a manufacturing defect. The plastic port housing and port reservoir may separate because of this defect.

The affected product has been distributed worldwide. The recall involves 3 units with UDI/DI 10610586012518 and Lot Number 4235595.

Patients or healthcare providers who have this device should contact Smiths Medical ASD, Inc. for instructions on what steps to take regarding the recalled product.

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
  • device-separation
  • implant-failure

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