Z-0812-2019Class I

vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model...

Name: Z-0812-2019 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model...
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 vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1... 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-0812-2019
Classification: Class I
Status: Open, Classified
Initiated: 2019-01-17
Posted: 2019-02-14
Recalling firm: Medtronic, Inc.
Product: vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
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: 47086 units
Distribution: Wordlwide
Product codes and lots: vitatron (implantable pulse generator): (a) A-series, Model Number: A30A1, GTIN 00643169709331; A60A1, GTIN 00643169709294, All Serial Numbers (b) E-series, Model Number: E50A1, GTIN 00643169709126, 00643169709140; E60A1, GTIN 00643169709164, 00643169709188, All Serial Numbers (c) G-series, Model Numbers: G70A1, GTIN 00643169709249, 00643169709263; G70A2, GTIN 00643169883000, All Serial Numbers (d) Q-series, Model Number: Q50A2, GTIN 00643169883017; Q70A2, GTIN 00643169882980; Q80A2, GTIN 00643169882997, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2019
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)