FDA (Devices) recall action 88369
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.
Potential for leaks and loosening at the patient catheter connection
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 TheraSphere Administration Sets due to potential for leaks and loosening at the patient catheter connection. The recall affects 4980 sets distributed worldwide.
Boston Scientific is recalling TheraSphere Administration Sets due to potential leaks and loosening at the patient catheter connection. Approximately 4,200 sets were distributed worldwide.