FDA (Devices) recall action 94796
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
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.
Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.
The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.
Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.
Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.