FDA (Devices) recall action 88821
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.
There is a potential for distal tip dislodgement or separation.
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.
Cordis Corporation is recalling the SMART FLEX Biliary Stent System (Lot 266586) due to potential distal tip dislodgement or separation. Affected units were distributed to select US states and Canada.
Cordis is recalling the SMART FLEX 6x150 BIL biliary stent system due to potential separation of the distal tip. Approximately 26 units were distributed in the U.S. and Canada. Affected patients should contact their healthcare provider.
Cordis Corporation is recalling 4 units of the SMART FLEX 10x100 BIL biliary stent system (Lot No. 271626) due to a potential for distal tip dislodgement or separation. The affected units were distributed in the US and Canada.
Cordis Corporation is recalling SMART FLEX biliary stent systems due to a potential risk that the distal tip may dislodge or separate, which could compromise the stent's function.
Cordis Corporation is recalling 9 SMART FLEX 9x60 biliary stent units due to a potential for distal tip dislodgement or separation. The stents were distributed to patients in several U.S. states and Canada.
Cordis Corporation is recalling 3 units of SMART FLEX 6x120 BIL biliary stents due to a potential for distal tip dislodgement or separation. No illnesses or injuries have been reported.