Z-0810-2019Class I

Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR)...

Name: Z-0810-2019 Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR)...
Creator: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Published: 2019-01-17
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2019-01-17 / Open, Classified / root cause: design

FDA source

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) began a recall of Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1 on 2019-01-17. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0810-2019
Classification: Class I
Status: Open, Classified
Initiated: 2019-01-17
Posted: 2019-02-14
Recalling firm: Medtronic, Inc.
Product: Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
Product code: NVZ Pulse Generator, Permanent, Implantable
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
Root cause tag: design
FDA root cause: Component design/selection
Action: In the US, beginning 17-Jan-2019, Medtronic Field Representatives hand deliver an FCA Notification Letter to consignees including implanting and follow-up physicians. In consultation with an Independent Physician Quality Panel (IPQP), patient management recommendations were provided with the FCA Notification letter to ensure patient safety. Medtronic Field Representatives will hand deliver an additional Supplemental Letter with the Urgent Medical Device Recall letter to a subset of physicians with patients whose device has shown evidence of a pacing pause that is potentially related to this circuit error. Consignees will be asked to return all unused and unopened affected product to Medtronic.
Quantity in commerce: 5392 units
Distribution: Wordlwide
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0806-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0807-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0808-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0809-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0810-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0811-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14
Z-0812-2019	Class I	Ongoing	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code NVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)