Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Acandis GmbH, issued a medical device safety alert concerning DERIVO 2 Embolisation Device [article numbers: 01-107001, 01-107002, 01-107003, 01-107004, 01-107005, 01-107006, 01-107007, 01-107008, 01-107009, 01-107010, 01-107011, 01-107012, 01-107039, 01-107043, 01-107047, 01-107048, 01-107052, 01-107053, 01-107057, 01-107058] [HKMD No.: 200381].
The manufacturer has received an increasing number of complaints from customers who have reported difficulty in delivery of devices through the catheter in certain sizes. Product sizes whose article numbers are not listed here are not affected by the corrective action and can continue to be used without restriction.
According to the manufacturer, under certain circumstances, this described problem leads to a potentially dangerous situation for the patients. However, in addition to a significant prolongation of the procedure and thus also a prolongation of the duration of anesthesia and fluoroscopy, there are also possible damages resulting from this situation. For patients who have already been implanted with a DERIVO 2 Embolisation Device, there is no increased risk, as the described problem is limited to the delivery (i.e. before implantation).
The manufacturer is calling for return of the aforementioned article numbers immediately.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jan 2022