Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
Check against the official notice below — it lists the full affected range.
Medtronic Inc. is recalling 7,469 dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta, Versa, and Sensia. The affected models are RED01, REDR01, and REVDD01. These devices may experience a circuit error that affects device functionality when programmed to dual chamber mode with atrial-sensing.
The recall affects pacemakers with all serial numbers of the three affected models. The source document does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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 Quantity: 7469 units Lot/code info: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01, GTIN: 00643169709003, All Serial Numbers (b) Model Number REDR01, GTIN: 00643169708990, 00643169969742, All Serial Numbers (c) Model Number REVDD01, GTIN: 00643169709010, 00643169969773, All Serial Numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.