The Recall Desk

FDA (Devices) recall action 88107

Boston Scientific Corporation recalled 6 products on 2021-07-21

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2021-07-21
Critical
0
Units
91,139

Why these products were recalled

The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator) when the device's battery exhibits high internal impedance. This latent battery condition puts a device at risk for system resets to occur due to temporary high-power consumption related to telemetry attempts and subsequent reversion to Safety Mode to maintain back-up pacing. Although therapy is still provided when a device is in Safety Mode, replacement is required. - Only dual chamber INGENIO …

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.

1–6 of 6

  • SevereFDA (Devices)··2021-07-21

    INGENIO DR EL Pacemakers Recalled: Defective Battery May Trigger Safety Mode

    Dual chamber INGENIO DR EL pacemakers with Extended Life batteries may develop high internal impedance, causing devices to enter Safety Mode later in life. Affected patients should contact their healthcare provider about replacement.

    Product
    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-07-21

    Boston Scientific INLIVEN CRT-P Pacemakers Battery Impedance Recall

    Boston Scientific recalls dual chamber INGENIO family pacemakers and CRT-Ps with Extended Life batteries that may develop high internal impedance, causing Safety Mode and system resets, requiring device replacement.

    Product
    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-07-21

    INTUA CRT-P Pacemakers Recalled Due to Battery Degradation Risk

    The INTUA CRT-P pacemakers (1,707 units) may develop high internal battery impedance later in device life, causing system resets and triggering Safety Mode. Therapy continues but device replacement is required.

    Product
    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-07-21

    VITALIO DR EL Pacemakers Recalled Due to Battery-Related Device Resets

    Boston Scientific is recalling VITALIO DR EL pacemakers with Extended Life batteries due to a latent battery condition that may cause unexpected device resets and Safety Mode activation later in device life.

    Product
    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-07-21

    Boston Scientific INGENIO CRT-P Pacemakers Recalled for Battery Defect

    Boston Scientific is recalling INGENIO CRT-P pacemakers that may develop high internal battery impedance, causing unexpected device resets and Safety Mode activation. Affected devices require replacement.

    Product
    INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2021-07-21

    Boston Scientific ADVANTIO DR EL Pacemakers Recalled for Battery Malfunction

    Boston Scientific is recalling ADVANTIO DR EL dual chamber pacemakers and CRT-Ps due to a latent battery condition that may cause system resets and trigger Safety Mode, requiring device replacement.

    Product
    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
    Category
    Distribution
    0 states