The Recall Desk

FDA (Devices) recall action 72855

Boston Scientific Corporation recalled 2 products on 2016-01-20

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2016-01-20
Critical
0
Units
8

Why these products were recalled

The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR pacemaker.

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.

1–2 of 2

  • ModerateFDA (Devices)··2016-01-20

    Boston Scientific MRI PROPONENT SR Pacemaker Recall for Incorrect Literature Labeling

    Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.

    Product
    Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-01-20

    Boston Scientific Recalls Three Pacemakers Due to Incorrect Literature Packet

    Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.

    Product
    Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
    Category
    Distribution
    0 states