Medical technology company Medtronic is facing recalls of its dialysis catheters for the second time. The US Food and Drug Administration (FDA) has announced that Medtronic is recalling around 210,000 catheters due to potential separation of their parts. This separation could lead to blood clotting or embolism, causing serious health problems for patients. The catheters in question were manufactured and distributed between July 2011 and September 2020. There have been around 33 complaints relating to the issue, with one reported death. Medtronic has advised healthcare providers to stop using the recalled catheters and to remove them from inventory.
This latest recall comes after a previous recall of Medtronic’s dialysis catheters in 2020 due to the potential for the Medicines and Healthcare products Regulatory Agency (MHRA) regulatory actions against the company. The latest recall highlights the ongoing challenges faced by Medtronic in maintaining the safety and quality of their medical devices. The company will need to address these concerns and take necessary actions to regain the trust of patients and healthcare providers.