Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 units distributed worldwide.
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 recall is classified as FDA Class I, which establishes a minimum severity of Severe according to recall classification standards. No deaths or reported injuries are documented in the source.
Plain-English summary
Smiths Medical ASD, Inc. is recalling ProPort Plastic Venous Access System components (PolyFlow Polyurethane Catheter, 1.9mm O.D., REF 21-4152-24) due to a manufacturing defect. The plastic port housing and port reservoir may separate from each other.
The recalled units were distributed worldwide. The defect affects 2,311 units across 41 identified lot numbers. Healthcare facilities and patients with implanted devices should contact their healthcare provider or Smiths Medical for guidance. Additional information is available from the FDA.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 2,311
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 10610586012549
- Lot Numbers: 3928188
- 3953708
- 3957301
- 3968097
- 3977434
- 3988450
- 4006475
- 4022600
- 4027912
- 4036893
- 4073108
- 4086999
- 4103105
- 4114110
- 4122783
- 4136362
- 4139518
- 4152689
- 4153871
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 →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · device separation
See all →- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereSmiths Medical ProPort Venous Ports Recalled for Potential Housing Separation
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Plastic Venous Access System Recalled
FDA (Devices) · 2025-03-26