Important Safety Alerts

Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Amphirion Deep Percutaneous Transluminal Angioplasty (PTA) Balloon Dilation Catheter. The affected products are identified as follow:

• Model number:
  AMD015020002, AMD020120152, AMD025150152, AMD030150152, AMD040120002, AMD335210002, AMD015020151, AMD020150002, AMD030040002, AMD035040152, AMD040120152, AMD335210152, AMD015020152, AMD020150152, AMD030040152, AMD035120002, AMD040150002, AMD354210002, AMD020040002, AMD025040152, AMD030080002, AMD035150002, AMD040150152, AMD354210152, AMD020040152, AMD025080152, AMD030080152, AMD035150152, AMD225210002, AMD020080002, AMD025120002, AMD030120002, AMD040040152, AMD225210152, AMD020080152, AMD025120152, AMD030120152, AMD040080002, AMD253210002, AMD020120002, AMD025150002, AMD030150002, AMD040080152, AMD253210152

Medtronic is conducting a voluntary urgent medical device recall of the affected products due to a potential breach of pouch seal for the product manufactured in select lots.

According to the manufacturer, they did not receive any customer complaint or report of adverse patient events regarding improperly sealed pouches. The potential for the breach in the pouch enclosing the sterilized product was discovered during internal packaging testing, which involved exposure to extreme use conditions.

The manufacturer requests the customers to identify and quarantine all unused, affected product in their inventory, and return them to the manufacturer. Patients who have received treatment with the devices affected by the recall should continue to be monitored in accordance with the physician's standard practice.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 26 October 2015