Agency classClass IOur severity:Severe FDA (Devices)·Z-1280-2025·Announced 2025-03-26

Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect

Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.

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 classification applies, establishing a minimum severity threshold. The manufacturing defect causing separation of an implantable port housing and reservoir represents a structural failure of an implanted medical device. Although no illnesses or injuries have been reported, the defect poses serious potential harm through impaired device function.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 9,506 units of the ProPort Plastic Implantable Venous Access System (model REF 21-4153-24) because the plastic port housing and port reservoir may separate due to a manufacturing defect. This could result in loss of device function.

The affected devices were distributed worldwide. Specific lot numbers are identified in the recall notice. Patients who have received one of these devices should contact their healthcare provider to determine if they are affected and discuss next steps.

No illnesses or injuries have been reported in connection with this defect. The FDA classified this as a Class I recall, indicating the potential for serious adverse health consequences from device failure.

The recalled product

Product: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Implantable Venous Access Port
Hazard: device-separation
implant-failure
loss-of-function
Affected units: 9,506

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 10610586012563
Lot Numbers: 3926121
3928189
3953709
3957303
4006476
4008521
4036894
4046803
4096337
4108664
4114114
4114115
4136363
4146466
4153872
4173601
4232305
4235508
4235598

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 →

Same manufacturer · Smiths Medical ASD, Inc.

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