FDA-Device2019-02-20Class I
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
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
Sold states
Wordlwide
Affected count
7469 units
Manufactured in
8200 Coral Sea St Ne, N/A, Mounds View, MN, United States
Products
Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2019Don't want to check this manually?
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