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Recall Observatory FDA recall evidence

Device product

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

Z-0808-2019

January 17, 2019

Class I

Product summary

Firm
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Event
Event 81945
Status
Ongoing
Classification
Class I
Quantity
7469 units
Official record key
device-enforcement:Z-0808-2019

Official wording

Reason: 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

Code information: 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

Distribution pattern: Wordlwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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