Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning all former Sapheon (Covidien) VenaSea Closure Systems model SP-101.
The manufacturer is conducting a voluntary recall of all former Sapheon (Covidien) VenaSeal Closure Systems due to potential for sterility breach of the outer packaging (pouch) material. A breach of the outer pouch may compromise the outside surface sterility of the sealed inner tray which does not directly affect the sterility of the device components.
The manufacturer has received one complaint potentially related to this issue resulting in an occurrence rate of 0.0253%. This complaint is associated with a serious patient injury; however it is unclear if this injury is device related. There have been no reports of death related to this issue.
According to the manufacturer, the breach in the pouch barrier may not be detectable by visual inspection of the product. While the device components within the sealed inner tray are not directly affected by this issue, the introduction of a non-sterile inner tray (outer surface of the inner tray contaminated) could potentially contaminate the sterile field and sterile personnel, thereby creating a possible indirect pathway for microbes to come in contact with the patient, which may cause an infection. If a patient has received treatment with a VenaSeal Closure System, no action is required and patients should continue to be monitored in accordance with standard of care.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 4 May 2015