Product Wiki · Recalls · U.S. FDA — Device Enforcement

PROPONENT EL DR Pacemaker — recall Z-0375-2018

U.S. FDA — Device Enforcement · United States · 2017-12-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0375-2018
Date of alert
2017-12-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: 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).
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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