Medtronic is having another product safety problem, this time in Europe.
In June, the company put out an Urgent Field Safety Notice to healthcare professionals in Europe for a list of cardiac defibrillators after discovering that some devices were delivering a reduced shock during high voltage therapy.
As of June 3, Medtronic has discovered 27 devices that have experienced a reduced shock, according to a notice posted Wednesday by Germany’s Federal Institute for Drugs and Medical Devices. The affected devices are several models each of Cobalt, Cobalt XT and Crome defibrillators.
Medtronic has not received any reports of permanent harm or death due to the issue, and it is asking customers to quarantine and return unused affected products. According to the notice, the company has submitted a device software update to address the issues, which it expects to be available for download at the beginning of the third or fourth quarter of 2022, pending regulatory approvals.
This is not Medtronic’s first issue with defibrillators. In April 2021, the Food and Drug Administration published a Class I recall notice affecting nearly 240,000 devices due to “an unexpected and rapid decrease in battery life.” There were 444 complaints associated with the recall and 18 injury reports, according to the FDA.
While that recall impacted many devices, the Cobalt and Crome products were not listed.
