Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Antibiotic Impregnated (ARES) Catheters (Part numbers: 91101, 93092, 95001).
According to the manufacturer, during routine post-sterilisation inspection, the manufacturer identified that there is a potential for a defect on the seal of the outer pouch of specific lots of the ARES Catheters.
It is reported that internal testing showed approximately 3 percent of pouches that are potentially impacted by this condition. This may compromise the sterility of the pouch contents, which may increase the risk of post-operative infection, requiring further medical intervention. To date, the manufacturer has not received any reports of patient harm or any complaints related to this issue.
Patients implanted with affected devices should be monitored in accordance with their medical facility's standard care protocols. Elective explantation or revision is not recommended for this issue. The manufacturer recommends the following to affected users:
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 14 December 2020