The Recall Desk

FDA (Devices) recall action 81945

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalled 7 products on 2019-02-20

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2019-02-20
Critical
0
Units
172,936

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • HighFDA (Devices)··2019-02-20

    Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error

    Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.

    Product
    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.

    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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.

    Product
    Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-02-20

    Medtronic SENSIA Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling SENSIA dual chamber pacemakers due to a potential circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: SENSIA, Dual chamber pacemaker (DDD): (a) Model Number SED01 (b) Model Number SEDR01 (c) Model Number SEDRL1
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2019-02-20

    Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
    Category
    Distribution
    0 states