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Regulatory Focus™ > News Articles > 2 > Medtronic Recalls Defibrillators Over Manufacturing Defect

Medtronic Recalls Defibrillators Over Manufacturing Defect

Posted 26 February 2018 | By Ana Mulero 

Medtronic Recalls Defibrillators Over Manufacturing Defect

A defect in the manufacturing process of certain Medtronic cardiac defibrillators, including implantable models, prompted a US Food and Drug Administration (FDA) Class I recall on Monday.

The Minneapolis-based device maker sent an urgent medical device recall notice to customers earlier this year after becoming aware of the manufacturing defect that called for corrective actions, such as offering supplemental device warranties for the affected models of two products – the Medtronic Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and the Implantable Cardiovert-Defibrillators (ICDs).

A total of nine CRT-Ds and 12 ICD models were affected and included in the recall.

FDA has now identified the recall as the most serious type because the identified defect may prevent the CRT-Ds and ICDS from delivering the life-saving, electrical shock therapies patients need.

The defect “causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest,” the agency said. “The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.”

As part of the corrective actions, Medtronic also directed care providers to consider replacing the affected ICDs – which include Evera and Visia models – with prophylactic devices.

Spokesperson Tracy McNulty told Focus that the company’s manufacturing processes “have been updated to prevent the specific manufacturing sequence associated with this issue from occurring.”

McNulty also confirmed “all physicians following the 48 patients with affected devices have been notified,” though due to “the nature of the issue, it is not possible to identify which of these 48 devices may fail or when they may fail.” She advised physicians “strongly consider explanting these 48 devices.”

Focus previously reported the number of medical device recalls has been steadily climbing over the years, reaching a total of 3,202 last year – up from 2,876 in 2016.

FDA Recall Notice


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