Agency classClass IOur severity:Severe FDA (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.

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 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: structural-defect
device-failure
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 →

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