Medical device manufacturer, Abbott, has issued a medical device safety alert concerning Ellipse implantable cardioverter defibrillators (ICDs) [Models: CD2377-36QC, CD2377-36C, CD1377-36QC, CD1377-36C; GMDN: 37265, 25852].
On 20 June 2019, the manufacturer began voluntarily recalling a small number (204 devices globally) of Ellipse ICDs from the customers and hospitals to prevent implant of devices that may have a latent vulnerability in the electronics circuitry.
According to the manufacturer, the Ellipse ICDs utilize aluminum wires to connect the high voltage components of the device, and the electronics are then encapsulated in epoxy. During final manufacturing testing, two electrical failures were identified in a limited lot of manufactured devices due to damaged aluminum wires. Based on the investigation, the manufacturer has decided to retrieve all non-implanted devices from this manufacturing lot and ensure the physicians that have all requisite information to care for patients implanted with an impacted device.
The manufacturer has currently received zero product performance complaints related to this issue. While the number of impacted devices is small, its investigation shows a total of thirty-six implanted devices are from this population. Though the manufacturer is not aware of no adverse patient events as a result of the issue, the potential patient impact could be the inability to deliver high voltage therapy. Analysis has estimated the probability of device failure to be very low, but there remains a potential for compromised high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
The physicians are requested to take the following actions:
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 June 2019