Z-1191-2024Class II

NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the...

Name: Z-1191-2024 NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the...
Creator: NxStage MDS Corporation
Published: 2024-01-29
License: https://open.fda.gov/license/

NxStage Medical Inc / initiated 2024-01-29 / Open, Classified / root cause: design

FDA source

NxStage MDS Corporation began a recall of NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter... on 2024-01-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1191-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-29
Posted: 2024-02-27
Recalling firm: NxStage Medical Inc
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.
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for recall: 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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 693
Distribution: US domestic distribution to Dialysis Centers located in AZ, CA, CO, GA, IL, IN, MA, MD, MI, MN, MO, MS, NC, NJ, NY, TN, TX, VA, WI. No international distribution.
Product codes and lots: UDI-DI M535CAR5350; Package DI M535CAR5355 Lots 20878001, 30978013, 30978032, 31178011, 31178019

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1191-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1191-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-27

Product code KDI

K183158Class IINxStage Cartridge Express with SpeedswapNxstage Medical, Inc. / cleared 2019-08-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)