Z-0806-2019 Class I Ongoing
FDA device recall Z-0806-2019 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: 41802 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
- 41802 units
Product Description
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
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
ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01, GTIN: 00643169708754, All Serial Numbers (b) Model Number ADDR01, GTIN: 00643169708587, 00643169708594, 00643169708600, 0643169708624, 00643169969711, All Serial Numbers (c) Model Number ADDR03, GTIN: 00643169708631, 00643169708648, All Serial Numbers (d) Model Number ADDR06, GTIN: 00643169708655, 00643169708662, All Serial Numbers (e) Model Number ADDRL1, GTIN: 00643169518247, 00643169708679, 00643169708686, 00643169708709, 00643169969803, All Serial Numbers (f) Model Number ADDRS1, GTIN: 00643169708716, 00643169708723, 00643169708730, 00643169708747, 00643169969810, All Serial Numbers (g) Model Number ADVDD01, GTIN: 00643169708761, 00643169708778, 00643169969735, All Serial Numbers