Recall Z-0359-2018— Boston Scientific Corporation

Name: FDA recall Z-0359-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-07

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-12-07. FDA's recall record names no specific 510(k) clearance for this event. Product: ACCOLADE MRI EL DR Pacemaker. Reason: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers)..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2017-12-07
Firm location: Saint Paul, MN, United States

Product description

ACCOLADE MRI EL DR Pacemaker

Reason for recall

Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).

Data sourced from openFDA. This site is unofficial and independent of the FDA.