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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Implants & Prosthetics

ProPort Plastic Implantable Ports Recalled for Reservoir Separation Risk

Agency Publication Date: March 18, 2025
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Summary

Smiths Medical ASD, Inc. has recalled 30,146 ProPort Plastic Implantable Ports because of a manufacturing defect. The plastic housing and the internal reservoir of these devices may separate, which can prevent proper delivery of medication or cause treatment fluids to leak into surrounding body tissues. If you have one of these systems implanted, you should contact your healthcare provider or Smiths Medical immediately.

Risk

The plastic port housing and reservoir may separate while the device is inside a patient's body. This could lead to serious medical complications including treatment interruption, internal leaks, or the need for surgical removal and replacement of the device.

What You Should Do

  1. This recall affects multiple models of the ProPort Plastic Venous Access System and ProPort Low Profile Plastic Venous Access System with various catheter types. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled devices immediately.
  3. Contact Smiths Medical or your medical distributor to arrange for the return, replacement, or correction of any unused inventory.
  4. If you are a patient with a ProPort device currently implanted, contact your healthcare provider to discuss your treatment plan and to check the status of your implanted device.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information about medical device recalls and safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87mm O.D. (8.4Fr) x 1.0mm I.D.
Variants: Silicone Catheter, 2.87mm O.D., 8.4Fr, 1.0mm I.D.
Model / REF:
21-4150-24
Lot Numbers:
4235595
UDI:
10610586012518

Quantity: 3 units

Product: smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer
Variants: Silicone Catheter, 2.8mm O.D., 8.4Fr, 1.0mm I.D., 9 Fr Introducer
Model / REF:
21-4151-24
Lot Numbers:
3968088
4052396
4063411
4101698
4122782
4219344
4232319
4235596
4242786
4317072
4325879
4397749
4420759
4445594
4449874
UDI:
10610586012532

Quantity: 643 units

Product: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D.
Variants: PolyFlow Polyurethane Catheter, 1.9mm O.D., 5.8 Fr, 1.0mm I.D.
Model / REF:
21-4152-24
Lot Numbers:
3928188
3953708
3957301
3968097
3977434
3988450
4006475
4022600
4027912
4036893
4073108
4086999
4103105
4114110
4122783
4136362
4139518
4152689
4153871
4173433
4189866
4222392
4227822
4235597
4276226
4307472
4317085
4349806
4378522
4387732
4395511
4460618
4434228
4449233
4449875
6013082
6014983
4468606
4426417
6062037
6071256
UDI:
10610586012549

Quantity: 2311 units

Product: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer
Variants: PolyFlow Polyurethane Catheter, 1.9mm O.D., 5.8Fr, 1.0mm I.D., 6Fr Introducer
Model / REF:
21-4153-24
Lot Numbers:
3926121
3928189
3953709
3957303
4006476
4008521
4036894
4046803
4096337
4108664
4114114
4114115
4136363
4146466
4153872
4173601
4232305
4235508
4235598
4271453
4291483
4294059
4317075
4317092
4358052
4366693
4366694
4387733
4434229
4449244
4453603
4453604
4453605
6001912
6026649
6051324
6062012
6071257
6077416
UDI:
10610586012563

Quantity: 9506 units

Product: smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D.
Variants: PolyFlow Polyurethane Catheter, 2.6mm O.D., 7.8Fr, 1.6mm I.D.
Model / REF:
21-4155-24
Lot Numbers:
3926119
3928191
3944833
3960347
3968098
3988451
4027913
4057817
4087000
4139520
4146467
4173474
4196758
4221725
4235599
4256939
4291484
4295931
4302979
4307473
4307474
4437254
4447572
4449876
4460619
6037144
6006017
6059285
6026682
6062025
6071258
UDI:
10610586012594

Quantity: 3263 units

Product: smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer
Variants: Pre-assembled, PolyFlow Polyurethane Catheter, 2.6mm O.D., 7.8Fr, 1.6mm I.D., 8.6Fr Introducer
Model / REF:
21-4165-24
Lot Numbers:
3918902
3984420
4079312
4189868
4221726
4235543
4242787
4294897
4307477
4356314
4364692
4390226
4445595
4468593
6003890
UDI:
10610586012686

Quantity: 1695 units

Product: smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer
Variants: PolyFlow Catheter, 2.6mm O.D., 7.8Fr, 1.6mm I.D., 8.5Fr Introducer
Model / REF:
21-4171-24
Lot Numbers:
3941279
3969275
3984421
4022601
4136364
4148590
4153873
4196768
4227788
4232310
4235600
4248718
4276227
4302980
4307478
4317093
4325880
4358053
4358054
4395512
4415445
4420760
4437255
4449234
4449877
4460620
6013083
6003891
6053532
6062026
UDI:
10610586012716

Quantity: 1961 units

Product: smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D.
Variants: Pre-assembled, PolyFlow Polyurethane Catheter, 2.6mm O.D., 7.8Fr, 1.6mm I.D.
Model / REF:
21-4172-24
Lot Numbers:
4235509
UDI:
10610586012723

Quantity: 1 unit

Product: smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introducer
Variants: Pre-assembled, PolyFlow Polyurethane Catheter, 2.6mm O.D., 7.8Fr, 1.6mm I.D., 8.5Fr Introducer
Model / REF:
21-4173-24
Lot Numbers:
4317077
UDI:
10610586012747

Quantity: 12 units

Product: smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24
Variants: Implantable Venous Access Systems
Model / REF:
82-24
Lot Numbers:
4196769
UDI:
10610586012754

Quantity: 0 units

Product: smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer
Variants: Low Profile, PolyFlow Polyurethane Catheter, 1.9mm O.D., 5.8Fr, 1.0mm I.D., 6Fr Introducer
Model / REF:
21-4183-24
Lot Numbers:
3916028
3969277
4006477
4022602
4036895
4057818
4060894
4096338
4108453
4114117
4146468
4153874
4163556
4196775
4221727
4235565
4235567
4235601
4248694
4256927
4256928
4256964
4276228
4294894
4294895
4364693
4366695
4366696
4378523
4382349
4392370
4395513
4405010
4420761
4426418
4434230
4453606
4468579
4468580
6005957
6005958
6026650
6026651
6037122
6037124
6051325
UDI:
10610586012778

Quantity: 8515 units

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
Variants: Low Profile, Silicone Catheter, 2.8mm O.D., 8.4Fr, 1.0mm I.D., 9Fr Introducer
Model / REF:
21-4187-24
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
UDI:
10610586012839

Quantity: 2236 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96294
Status: Active
Manufacturer: Smiths Medical ASD, Inc.
Sold By: hospital suppliers; medical distributors
Manufactured In: United States
Units Affected: 12 products (3 units; 643 units; 2311 units; 9506 units; 3263 units; 1695 units; 1961 units; 1 unit; 12 units; 0 units; 8515 units; 2236 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.