Food, drugs, devices › NxStage Medical, Inc.

Device recall: NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.

FDA enforcement event 72554 · Class II · initiated 29 Oct 2015 · status Terminated · terminated 19 Nov 2019

DeviceVoluntary: Firm initiated3 product recordsLawrence, MA

NxStage Medical, Inc. (Lawrence, MA) initiated this device recall on 29 Oct 2015; FDA lists 3 product records under event 72554, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 19 Nov 2019. Initiation: voluntary: firm initiated. NxStage Medical, Inc. has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

NxStage Medical, Inc., Lawrence, MA.

Reason for recall

"Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed"

Distribution

"Worldwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0335-2016	NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.	2,134 units	Class II	Terminated	2 Dec 2015
Z-0336-2016	NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.	133 units	Class II	Terminated	2 Dec 2015
Z-0337-2016	NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4	7 units	Class II	Terminated	2 Dec 2015

Context

91%of 2015 device events are Class II1,153 events that year

3product records in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for NxStage Medical, Inc.

Initiated	Product (first record)	Type	Class	Records
28 Apr 2025	NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF	Device	Class II	1
14 May 2024	NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-	Device	Class II	1
27 Aug 2019	Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage Ver	Device	Class II	1
11 Apr 2019	NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with rena	Device	Class II	2
17 Oct 2018	NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for u	Device	Class II	8
11 Jun 2018	NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Wa	Device	Class II	1
29 Jan 2018	NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030,	Device	Class II	1
10 Nov 2017	NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One	Device	Class II	1
29 Oct 2015	NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5	Device	Class II	2
14 May 2014	NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium 140,	Device	Class II	8

All 13 events for NxStage Medical, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Nov 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.