Important Safety Alerts

Medical device manufacturer, Medtronic, has issued an urgent medical device recall concerning its unused DLP Left Heart Vent Catheters, 16 Fr [Model Numbers: 12116]; DLP Left Heart Vent Catheters, 18 Fr [Model Numbers: 12118].

The manufacturer is voluntarily recalling the affected product due to the potential for a wire protrusion through the left heart vent catheter tip. If unnoticed prior to the procedure, this wire protrusion could lead to tissue damage (abrasion/perforation) and thereby to a longer duration of the procedure and/or surgical repair. According to the manufacturer, through 9 Aug 2021, it has received fourteen complaints involving this issue. Three of these reported tissue damage or perforation, requiring surgical repair.

The manufacturer recommends the following to affected users:

• Identify, quarantine and return all unused affected product.
• For those affected product that have been used in surgery, patients should be monitored for bleeding in post-op care.
• Report any adverse reactions or quality problems to the manufacturer if the quality issue described above has been observed.

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 31 Aug 2021