FDA (Devices) recall action 65317
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.
Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
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 27 NephroMax high pressure nephrostomy balloon catheters because they were packaged with incorrectly sized renal sheaths.
Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.