Convatec issued an urgent field safety notice in Europe to warn of issues with its Avelle negative pressure wound therapy (NPWT) pump.
The Avelle pump is a battery-powered device for use on patients that would benefit from a NPWT device with a low-to-moderately-exuding wound, such as chronic wounds like leg ulcers, acute wounds, dehisced wounds, flaps and grafts and surgically closed incision sites, according to the notice.
Avelle uses a sterile dressing of gelling fiber technology to absorb wound exudate with negative pressure applied through a vacuum pump. A single Avelle dressing may be worn up to seven days but may be changed sooner depending on the level of exudate and clinical need.
The company said in the notice that the Avelle pump kit contiains an unapproved leur lock connector located on the male end of the tube, which could cause hazards such as tissue damage, non-penetrating wounds, inconvenience and infection.
Convatec said users are to immediately identify any affected devices, quarantine and destroy them. Customer reply is required within 30 days and the manufacturer actions include product removal and on-site modification/inspection.