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
Check against the official notice below — it lists the full affected range.
Medtronic is recalling approximately 41,802 dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta, Versa, and Sensia. These devices may experience a circuit error when programmed to dual chamber mode with atrial-sensing that could affect how the pacemaker functions. The recall affects specific model numbers including ADD01, ADDR01, ADDR03, ADDR06, ADDRL1, ADDRS1, and ADVDD01, identified by their serial numbers and product codes (GTINs).
The product information provided does not specify a remedy or what affected consumers should do in response to this recall.
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: 41802 units Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.