FDA MedWatch: Implantable Port Recall

Smiths Medical Removes ProPort Plastic Implantable Ports Due to Manufacturing Error that May Cause Separation

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Smiths Medical is recalling ProPort Plastic Implantable Ports due to a manufacturing defect that may cause the plastic port housing and port reservoir to separate before, during, or after implantation. The use of affected product may cause serious adverse health consequences, including complications from the delay or interruption of life-saving therapies, damage or scarring to skin or tissue surrounding the port from contact with leaking intravenous medications such as chemotherapy, air entering the bloodstream (air embolism), and death.

There have been two reported injuries. There have been no reports of death.

Device Use

ProPort Plastic Implantable Ports are part of a system for accessing veins (venous access) that includes the plastic port, a silicone or polyurethane catheter, a catheter connector, a Port-A-Cath access needle, a blunt needle, and a vein pick. ProPort systems are used when patient therapy requires repeated venous access for injections, infusions, and/or blood samples.

What to Do

  • Do not use ProPort Implantable Plastic Port from affected lots.
  • Monitor patients who already have implanted ProPort Implantable Ports for signs of any adverse events.