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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: Medtronic Recalls

A House committee, in response to the recent Class I recall of Sprint Fidelis defibrillator leads, is requesting additional information from the FDA on its regulation of heart-device components, specifically defibrillator leads.

In a letter sent to FDA Commissioner Andrew von Eschenbach, the House Oversight and Government Reform Committee requested information regarding the agency's approval and oversight of Medtronic's Sprint Fidelis defibrillator leads and other devices of this type.

The letter dated October 22 follows a recall of the leads due to potential fractures.

Concerns have been raised by some about whether the FDA required additional preapproval testing for these heart-device components, said the letter.