Z-0808-2019 Class I Ongoing
FDA device recall Z-0808-2019 was initiated by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) on January 17, 2019 and is designated Class I. 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 wit… The recall status is ongoing. Affected quantity: 7469 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2019
- Initiation Date
- January 17, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7469 units
Product Description
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 Pattern
Wordlwide
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