Medical device manufacturer, Biosensors International, has issued a field safety notice concerning BioPath 035, with the following details:

• Model BPTH-35-60100L (Balloon diameter 6.0 x 100mm length – catheter length 135cm)
• All lot numbers for this model manufactured prior to November 2014 are affected.

The manufacturer has received a report regarding a compatibility issue with the recommended sheath introducer size. The product is currently labelled for a 5F sheath introducer compatibility when the product specification is indicating a 6F recommendation.

According to the manufacturer, this mislabeling has no impact on patient safety but it may lead to a prolonged procedure. Patients who have already been successfully treated with an affected device are not impacted by this action.

The manufacturer advises users to identify and quarantine the affected products. They will contact the affected users to arrange the corrective action.

According to the local supplier, the affected product is distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 23 February 2015