FDA (Devices) recall action 92072
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.
The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
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 recalls 1,300 WATCHDOG Hemostasis Valve Kits due to insertion tool occlusion that prevents guidewire passage. Affected units were distributed worldwide.
Boston Scientific's Watchdog Accessory Kit is being recalled because the insertion tool component can become occluded, preventing guidewire passage. The recall affects 10,833 units distributed worldwide.