NxStage Medical, Inc.: Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;

Recall number

Z-0697-2020

Recalling firm

NxStage Medical, Inc.

Product

Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage VersiHD Cycler, Model Numbers: NX1000-16, and NX1000-16-A; 3) NxStage One, Model Numbers: NX1000-3 and NX1000-3-A; 4) NxStage One, Model Numbers: NX1000-10 and NX1000-10-A;

Status

Terminated

Initiated

2019-08-27

Posted

not on file

Terminated

2021-02-01

Reason

There is a potential patient health risk while performing chronic hemodialysis treatments in the home setting with for patients with low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) when prescribing larger dialysate volumes.

Root cause

Under Investigation by firm

Action

On August 27, 2019, NxStage issued URGENT MEDICAL DEVICE CORRECTION notices to customers. Actions to be Taken by Customers: For patients using NxStage System One Cycler, model NX1000-1: - At any dialysate flow rate, the system may have a fluid removal error defined as the greater of 3% of Total Dialysate Volume or 300 ml/12hr. The Total Allowable Error is generally dependent on total dialysate volume processed for this System model. For patients using less than 10L of dialysate per treatment, this model has a minimum Total Allowable Error volume of 300 ml. For patients using NxStage System One S or NxStage VersiHD Cycler, model NX1000-3, NX1000-3A, NX1000-10, NX1000-10A, NX1000-16, or NX1000-16A: - At dialysate flow rates of 3.0 Liters/hour and below, the system may have a fluid removal error defined as the greater of up to 25 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. - At dialysate flow rates of above 3.0 Liters/hour, the system may have a fluid removal error defined as the greater of up to 100 ml/hour or 5% of Total Ultrafiltration Volume. The Total Allowable Error is dependent on the error rate and length of treatment and can continue to increase for as long as treatment is being delivered. NxStage discourages the use of the System for the treatment of low blood volume patients. If the physician considers it appropriate to prescribe home hemodialysis using the NxStage System One for low blood volume patients, the following points should be considered: 1. When performing hemodialysis treatments for low blood volume (2.4 Liters or less in a patient with body weight of 30kg or less) patients, NxStage strongly recommends employment of additional monitoring vigilance. Always ensure that cardiac status and fluid status are monitored for low blood volume patients by monitoring bloo

Quantity

1803 units

Distribution

AL, AZ, CA, NC & VA

Lot, serial or model codes

Product 1) UDI # - M535NX100010 Product 2) UDI # - M535NX1000160 and M535NX100016A0 Product 3) UDI # - M535NX100030 and M535NX10003A0 Product 4) UDI # - M535NX1000100 and M535NX100010A0   Lot Numbers:  60677021, 60877053, 70477033, 71177020, 80377002, 80477018, 80877011, 81077018, 81177047, 90277048 and 90677002

510(k) numbers

["K050525"]

PMA numbers

not on file

Product code

PEV

Firm FEI

3003464075

Firm city

Lawrence

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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