Dive Brief:
- Medtronic is recalling its Cobalt and Crome implantable cardioverter defibrillators from the U.S. because of a potential for reduced shock energy. The Class I recall covers more than 20,000 units.
- The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy, according to an enforcement report from the Food and Drug Administration.
- Medtronic had identified 41 devices with the problem as of Aug. 5, about .05% of all devices distributed worldwide, the company wrote in an emailed statement. The issue affects 61,000 devices in the U.S. and 28,000 devices internationally. Medtronic said it has not received reports of permanent patient harm or deaths due to the problem.
Dive Insight:
Medtronic sent an urgent field safety notice last month to healthcare providers in Europe about the same problem with the same product codes. The accompanying notification said the delivery of 79% of programmed energy will reduce the defibrillation efficacy by about 1%.
According to the June notice, Medtronic projects the problem will affect 0.18% of the products distributed globally within 24 months of service life. Potential harms include the “failure to terminate the arrhythmia due to reduced-delivered-energy, a theoretical risk of proarrhythmia, and complications associated with device replacement,” Medtronic said.
Medtronic received FDA approval and a CE Mark in Europe for a software update to mitigate the problem. It began deploying the update into devices that had already been implanted in mid-August, while newly manufactured devices will have the update pre-installed, the company wrote in an email.
The company is advising against prophylactic device removal. Physicians should only consider replacing devices after observing and confirming a reduced energy event with a Medtronic representative. When assessing whether to replace a device, physicians should consider the 81% probability of delivering subsequent reduced-energy shocks and the expectation that an update will fix the issue this year, Medtronic added.
Last year, Medtronic recalled 240,000 defibrillators, none of which were in the Cobalt and Crome lines. The April 2021 Class I recall related to “an unexpected and rapid decrease in battery life” that was associated with 444 complaints and 18 injury reports.
