Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2019 - (Recall #: Z-0810-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: January 17, 2019

Date Posted: February 20, 2019

Recall Number: Z-0810-2019

Event ID: 81945

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

Status: Ongoing

Product Quantity: 5392 units

Code Information:

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

Distribution Pattern:

Wordlwide

Voluntary or Mandated:

Voluntary: Firm initiated