Recall Z-2017-2021— Boston Scientific Corporation

Class I FDA medical device recall by Boston Scientific Corporation, initiated 2021-06-03. FDA's recall record names no specific 510(k) clearance for this event. Product: VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021). Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO family pacemakers and CRT-Ps built with the Extended Life (EL) battery are included within this advisory population.

Recalling firm

Boston Scientific Corporation

Classification

Class I

Status

Ongoing

Initiated

2021-06-03

Firm location

Saint Paul, MN, United States

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