Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): Medical Device Recall in 2019 - (Recall #: Z-0811-2019)

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: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01

Product Classification:

Class I

Date Initiated: January 17, 2019

Date Posted: February 20, 2019

Recall Number: Z-0811-2019

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: 2040 units

Code Information:

Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01, GTIN: 00643169708969, 00643169708983, 00643169709072, All Serial Numbers

Distribution Pattern:

Wordlwide

Voluntary or Mandated:

Voluntary: Firm initiated