FDA (Devices) recall action 84191
The FDA (Devices) publishes a recall like this one as 3 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 3 pages.
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not securely tighten to the biopsy needle. This could result in a delay in surgery.
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.
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially delaying surgery.
Medtronic Navigation is recalling Biopsy Needle FPU Kits because the depth stop may not tighten securely, potentially causing surgery delays.
Medtronic is recalling 10,448 Passive Biopsy Needle Kits because a manufacturing issue may cause depth stops to fail, potentially delaying surgery.