FDA recall Z-0808-2019

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · Class I · device

Product

Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01

Reason for recall

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

Distribution

Wordlwide

Key facts

Status: Ongoing
Initiation date: 2019-01-17
Report date: 2019-02-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mounds View, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0808-2019