FDA (Devices) recall action 86880
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.
Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.
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.
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stent Sets because trace amounts of nickel debris were found on the devices during manufacturing.
Boston Scientific is recalling 458 Contour VL Variable Length Ureteral Stents because trace amounts of nickel particles were found on the devices.