medical Class I Updated 2019-02-20

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic implantable pulse generator: Sphera DR MRI SureSc

Recalled Product

Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1

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: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01, GTIN 00643169882959, 00763000109097, All Serial Numbers (b) Model Number SPDRL1, GTIN 00643169882966, 00763000109103, All Serial Numbers

View official government recall

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