FDA (Devices) recall action 97295
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.
The catheters may not retain their shape.
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.
DLP Left Heart Vent Catheters, model 12115, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 25,261 units are affected.
DLP Left Heart Vent Catheters, model 12113, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 34,549 units are affected.
DLP Left Heart Vent Catheters, model 12110, are recalled because the catheters may not retain their shape. The FDA classified the action as Class I. 41,200 units are affected.