FDA (Devices) recall action 98922
The FDA (Devices) publishes a recall like this one as 6 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 6 pages.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with a 10 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with a 9 mm x 30 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.
CGuard Prime Carotid Stent Systems, 135 cm with an 8 mm x 40 mm stent, are being recalled because the delivery system may meet high resistance or fail to deploy the stent.