medical Class I Updated 2019-02-20

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic implantable pulse generator: ADAPTA, Dual chamber

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Wordlwide

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

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