NxStage MDS Corporation NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.
Brand
NxStage MDS Corporation
Lot Codes / Batch Numbers
UDI-DI M535CAR5350, Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
Products Sold
UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019
NxStage MDS Corporation is recalling NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating due to Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experien. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
Recommended Action
Per FDA guidance
The firm began notifying affected customers on January 29, 2024. Customers were informed that the issue may occur when the needleless access port located next to the filter has been accessed and there is a buildup of pressure in the circuit. Customers were instructed to inspect their inventory for affected product and quarantine recalled product. Customers should not use affected product and should ensure all users of the CAR-535 are aware of the notice. Customers should contact NxStage Customer Service at 1-866-NXSTAGE (1-866-697-8243) to arrange for the return of all affected products. This number may also be contacted if you have any questions or comments.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, CO, GA, IL, IN, MD, MA, MI, MN, MS, MO, NJ, NY, NC, TN, TX, VA, WI
Page updated: Jan 10, 2026