The US Food and Drug Administration (FDA) has added haemodialysis bloodlines to its medical device shortages list amid supply disruptions.
The agency expects the shortage to continue into late 2025 and has recommended healthcare providers adopt strategies to conserve device stockpiles.
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Also known as dialysis catheters, haemodialysis bloodlines, are sets of tubes that are inserted into a vein during dialysis treatment, connecting a patient’s bloodstream to the dialysis device. Dialysis machines filter blood and remove waste or excess fluid in patients with poor kidney function.
The FDA notice follows a customer letter sent by haemodialysis manufacturer B Braun in January 2025. The company explained that it was experiencing market disruption of the bloodline products.
“Due to additional supply and labour constraints over the holidays, our supplier has informed us that we will experience a further reduction in SL-2000M2095 production. Based on current inventory, we are expected to run out of product by January 20 with no additional releases planned in the foreseeable future,” B Braun stated in the letter.
B Braun is one of multiple medical device companies that manufacture haemodialysis bloodlines. According to GlobalData research, Medtronic and CR Bard occupy the joint-largest global market shares for the devices. The global market was worth $447m in 2024, as per analysis by GlobalData.
The FDA said it is working with manufacturers and dialysis providers to monitor the situation and ensure that bloodlines are available to patients who need them. The agency is also helping create solutions to minimise patient impact and is on standby to receive reports of supply chain concerns and shortages.
With haemodialysis bloodlines in short supply, the FDA is telling providers to develop strategies to conserve device use and monitor current and future supplies. The agency reiterated continuing to provide dialysis treatments to patients.
“The FDA will keep health care providers and the public informed as new or additional information becomes available,” the agency said in a statement.
B Braun listed products developed by Fresenius and Nipro as substitutes for its products. Fresenius Medical Care makes its bloodlines in countries, including Mexico and China, from which imports into the US have been impacted by tariffs by the federal government. So far, there has been no publicly disclosed disruption to the dialysis components.
This is not the first time the shortage of a haemodialysis component has impacted patient care. The American Society of Pediatric Nephrology (ASPN) reached out to the FDA in 2023 after difficulties in obtaining haemodialysis catheters for neonates and infants.
The agency has been keen to change the communication on medical device supply and is planning to amend laws signed during the pandemic to remove the current temporal limitation that ties device shortage reporting requirements to public health emergencies.
“The FDA recognises that early awareness of supply chain disruptions is essential to mitigating the impacts of potential medical device shortages on patient care and protecting the public health,” said Michelle Tarver, director of the FDA’s Center for Devices and Radiological Health (CDRH), in January this year.
An expert previously interviewed by Medical Device Network commented that the hyper-concentration of medical device manufacturing has impacted supply chain resilience and response speeds to shortages.
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