FDA (Devices) recall action 72855
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.
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.
Boston Scientific is recalling three PROPONENT MRI DR pacemakers because the included literature packet incorrectly describes the device type.
Boston Scientific is recalling five MRI PROPONENT SR pacemakers because the included literature incorrectly describes the device's pacing mode.