FDA (Devices) recall action 94775
The FDA (Devices) publishes a recall like this one as 8 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 8 pages.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
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.
Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.
Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.
Fresenius Medical Care is recalling Blood Pump Rotor components used in hemodialysis systems after reports of loose or dislodged guide sheaves during use. The defect affects 372 units distributed nationwide and in Canada.
Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.
Fresenius Medical Care is recalling approximately 1,156 blood pump rotor spare parts (Model F40015481 Rev A) distributed in the U.S. and Canada due to reports of loose or dislodged guide sheaves after clinical use.
Fresenius is recalling 17 Blood Pump Rotor spare parts nationwide due to loose or dislodged guide sheaves that develop after use. The affected rotor components are used in K@HOME dialysis machines.
Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.
Fresenius Medical Care is recalling hemodialysis blood pump rotor spare parts due to reports of loose or dislodged guide sheaves. The affected model is distributed nationwide in the U.S. and Canada.