Health Canada — Medical Devices · Canada · 2024-05-06 · Type II
🏛Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Reported risk: This is a field action notification by the manufacturer, Fresenius USA Inc. for Blood Pump Rotor Spare Parts that are compatible with 2008 series hemodialysis machine. The Blood Pump Rotor turns to move the blood along the blood pump segment of the machine. An increased number of complaints were reported to the manufacturer on the Blood Pump Rotor (p/n - f40015481 rev a, implemented in May 2020) after a period of use by clinics noting loose/dislodged guide sheaves. After thorough review of the complaints and root cause investigation, the manufacturer updated the Blood Pump Rotor design to p/n - f40015481 rev c to address customer complaints for bent guide pins due to improper unloading of blood lines. The rev a part was installed as a component of the arterial blood pump on the 2008 series hemodialysis machines during the period May 2020 till Apr 2024. The blood pump rotor is also sold as a spare part for the 2008 series blood pump module. Since, rev c design is now complete, and the part is now available, Fresenius USA has initiated a field action notification to conduct medical device correction if necessary. Recall start date: April 16, 2024
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.