FDA (Devices) recall action 88549
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.
Potential for a wire protrusion through the left heart vent catheter tip
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 51,494 DLP Left Heart Vent Catheters due to potential wire protrusion through the catheter tip. This defect could compromise proper device function during use.
Medtronic recalls DLP Left Heart Vent Catheters due to risk of wire protrusion through the catheter tip. The defect could cause internal injury during cardiac procedures.