Ellipse (defibrillator)

2019: A withdrawal of the rejected defibrillators which refuse to work

At the end of June, 2019 Abbott Laboratories began to withdraw voluntarily a part of Ellipse implanted a kardiovertera-defibrillator to prevent their further use. In devices of this type the vulnerability of the electronic circuit connected with the damaged wires was revealed.

As the producer notes, he did not receive any complaints to performance of a product or messages about the adverse phenomena connected with a problem.

Abbott withdraws the rejected defibrillators which refuse to work

According to the company, in the implanted kardioverter of Ellipse aluminum wires for connection of high-voltage components of the device are used. During final production tests in some of devices two electric faults connected with the damaged aluminum wires were detected.

On the basis of this research producers decided to recall from the market all not implanted devices from this production lot and to provide to health workers all necessary information for care of patients to which potentially rejected device was already implanted. In total from the market 204 devices should be recalled, however 36 of them were already implanted to patients.

According to Abbott, the impossibility of performing high-voltage therapy can become potential side effect of this defect. According to the analysis, the probability of this outcome is very low, but Abbott recommends to doctors to replace already implanted devices as they, perhaps, will not be able just to cope with the task. The voluntary response concerns models of the implanted Ellipse kardiovertera-defibrillator: CD1411-36Q, CD2411-36Q and CD2411-36C. At detection of these devices producers strongly recommend to address the local representative of Abbott.^[1]

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