FDAJanuary 17, 2019device

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and Sensia when programmed to a dual chamber mode with atrial-sensing, may experience a circuit error that affects device functionality

What to do

FDA enforcement status: Ongoing

Brands named

medtronic inc cardiac rhythm and heart failure crhfmedtronicmedtronic inc

UPCs

006431697093310064316970929400643169709126006431697091400064316970916400643169709188006431697092490064316970926300643169883000006431698830170064316988298000643169882997

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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