medical Class I Updated 2019-02-20

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

Recalled Product

Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1

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: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01, GTIN 00643169708914, All Serial Numbers (b) Model Number SEDR01, GTIN 00643169708877, 00643169708891, 00643169969780, All Serial Numbers (c) Model Number SEDRL1, GTIN 00643169708907, All Serial Numbers

View official government recall

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