FDA (Devices) recall action 88113
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
Due to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020.
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.
Medtronic is recalling CoreValve Evolut R Delivery Catheter Systems due to reports of actuator separation. The affected devices, manufactured before July 11, 2020, were distributed globally.
Medtronic is recalling CoreValve Evolut PRO PLUS Delivery Catheter Systems due to reports of actuator separation that could affect proper deployment of these cardiac devices.
Medtronic is recalling 67,339 CoreValve Evolut PRO Delivery Catheter Systems manufactured before July 11, 2020, due to reports of actuator separation that could affect device function.