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NxStage Medical, Inc.

United States·US-MF-000026832

Last updated September 17, 2026

What NxStage Medical, Inc. makes

NxStage Medical, Inc. manufactures haemodialysis systems for institutional and home use, including dialysate delivery units, dialysate solutions, and blood tubing sets. Their product portfolio also features various haemodialysis and blood collection needles, fluid warmers, and specialized cartridge sets for haemodialysis and haemofiltration procedures.

The company is based in the United States, and its devices are categorized under Class I, Class II, Class IIa, Class IIb, and U classifications. These products are listed in the FDA 510(k) and UDI databases, as well as the EUDAMED registry.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

Where is NxStage Medical, Inc. based?

NxStage Medical, Inc. is based in the United States. This information is provided directly by the company profile data, which identifies the country of origin for the manufacturer.

What types of medical devices does the company manufacture?

The company manufactures a range of haemodialysis equipment, including haemodialysis systems for institutional and home use, dialysate delivery units, dialysate solutions, and blood tubing sets. Additionally, their portfolio includes haemodialysis and blood collection needles, fluid warmers, and specialized cartridge sets for haemodialysis and haemofiltration procedures, as outlined in the provided device data.

How are the devices from NxStage Medical, Inc. classified?

The devices produced by the company are categorized under several regulatory classifications, specifically Class I, Class II, Class IIa, Class IIb, and U. These classifications reflect the regulatory framework under which the individual devices are managed.

Which registries list the devices manufactured by this company?

The devices manufactured by NxStage Medical, Inc. are listed in the FDA 510(k) database, the FDA UDI database, and the EUDAMED registry. These databases serve as the official repositories for tracking the regulatory status and identification of the company's medical devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 350, Merrimack Street, Lawrence, MA, United States
Website: nxstage.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Paula Rogalski
EUDAMED SRN: US-MF-000026832
FDA FEI Number: 3003464075
DUNS Number: —

Catalogue (289)

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Device	Model / Reference	Registries	Class	Status
Nx2me Connected Health Nx2me Clinician Portal	NX1380	FDA UDI	Class II	Unknown
NxStage PureFlow Solution	RFP-222-A	FDA UDI	Class II	Active
Fresenius Kabi Apheresis Needle with masterguard Anti-Stick Needle Protector	4R2441	FDA UDI	Class II	Active
NxStage SINGLE NEEDLE FISTULA SET	M9-3006	FDA UDI	Class II	Unknown
NxStage PureFlow B Solution	RFP-405	FDA UDI	Class II	Active
masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	D9-7004MGP	FDA UDI	Class II	Active
NxStage PureFlow B Solution	RFP-406	FDA UDI	Class II	Active
Pureflow Sl	NX2000-10-D	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-211-WW	FDA UDI	Class II	Active
Nxstage System One - Mobile Stand	NX0153	FDA UDI	Class I	Active
Nxstage System One Plus	NX1000-10-A	FDA UDI	Class II	Active
masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	D9-2006MGP	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-224-A	FDA UDI	Class II	Active
ButtonHole with SteriPick TWINPACK+ NEEDLE SET	BH-2005PE	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-207-A	FDA UDI	Class II	Active
Express Fluid Warmer Accessories	FW-301-1	FDA UDI	Class II	Active
Express Fluid Warmer Accessories	FW-300-1	FDA UDI	Class II	Active
ButtonHole with SteriPick TWINPACK+ NEEDLE SET	BH-2035PE	FDA UDI	Class II	Active
Nxstage Cartridge Express	CAR-172-WW	FDA UDI	Class II	Active
VersiHD	NX1000-10-D	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-209	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-205-WW	FDA UDI	Class II	Unknown
masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	D9-7005MGP	FDA UDI	Class II	Active
ButtonHole with SteriPick TWINPACK+ NEEDLE SET	BH-2037PE	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-204-A	FDA UDI	Class II	Active
masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	D9-2004MGP	FDA UDI	Class II	Active
masterguard APHERESIS NEEDLE	P9-7116MG	FDA UDI	Class II	Active
ButtonHole with SteriPick TWINPACK+ NEEDLE SET	BH-2004PE	FDA UDI	Class II	Active
Pureflow Sl	NX2000-8-EU	FDA UDI	Class II	Unknown
masterguard APHERESIS NEEDLE	P9-7118MG	FDA UDI	Class II	Active
NxStage PureFlow B Solution	RFP-400	FDA UDI	Class II	Active
Nxstage Cartridge Express	CAR-170-E	FDA UDI	Class II	Active
masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	D9-2005MGP	FDA UDI	Class II	Active
Nxstage Cartridge Express	CAR-170-C	EUDAMEDFDA UDI	Class II	Active
Pureflow Dialysate	RFP-209-CAN	FDA UDI	Class II	Active
Streamline Airless System Set with Locksite Needleless Access Sites	SL-2000M2095W	FDA UDI	Class II	Unknown
masterguard APHERESIS NEEDLE	P9-7115MG	FDA UDI	Class II	Active
masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	D9-7016MGP	FDA UDI	Class II	Active
NxStage PureFlow Solution	RFP-223-A	FDA UDI	Class II	Active
masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	D9-2015MGP	FDA UDI	Class II	Active
ButtonHole with SteriPick NEEDLE SET	BH-7005PE	FDA UDI	Class II	Active
NxStage PureFlow B Solution	RFP-454	FDA UDI	Class II	Active
ButtonHole with SteriPick TWINPACK+ NEEDLE SET	BH-2007PE	FDA UDI	Class II	Active
VersiHD with GuideMe software	NX1000-10-F	FDA UDI	Class II	Active
Medisystems Dialysis Priming Set	M4-9440	FDA UDI	Class II	Unknown
Pureflow Sl	NX2000-6	FDA UDI	Class II	Unknown
Nxstage Cartridge Express	CAR-502	FDA UDI	Class II	Active
NxStage PureFlow B Solution	RFP-402	FDA UDI	Class II	Active
NxStage PureFlow B Solution	RFP-404	FDA UDI	Class II	Active
Express Fluid Warmer	FW-301	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Fresenius Medical Care Deutschland GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (36)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

There are 36 recall records for NxStage Medical, Inc. initiated between April 14, 2004, and April 28, 2025, with statuses recorded as open, classified, or terminated. The reasons provided for these recalls include mislabeling, software errors affecting ultrafiltration volume, potential electrical fire risks, bag seal failures, pinhole leaks, and high conductivity failure alarms.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 28, 2025	Z-1864-2025	—	open, classified	Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
May 14, 2024	Z-2160-2024	—	open, classified	The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less than 2.0. The solution can be harmful if it comes in contact with the eyes or skin, and/or as a result of a slip or fall injury due to spilled fluid.
Aug 27, 2019	Z-0697-2020	—	terminated	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.
Apr 11, 2019	Z-1706-2019	—	terminated	Certain lots were mislabeled with incorrect product number.
Apr 11, 2019	Z-1707-2019	—	terminated	Certain lots were mislabeled with incorrect product number.
Oct 17, 2018	Z-0502-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0500-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0505-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0504-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0507-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0501-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0503-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Oct 17, 2018	Z-0506-2019	—	terminated	PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
Jun 11, 2018	Z-2793-2018	—	terminated	There is a potential risk of electrical fire when fluid leaks into the power receptacle on the back of the warmer. The risk exists any time the warmer is plugged in. The firm has received 7 reports of smoke, sparks, or flames coming from the Express Fluid Warmer since 2016. No adverse events have been reported.
Jan 29, 2018	Z-0811-2018	—	terminated	May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product.
Nov 10, 2017	Z-1132-2018	—	terminated	Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.
Oct 29, 2015	Z-0327-2016	—	terminated	Ultrafiltration (UF) Volume software error inaccurate fluid removal
Oct 29, 2015	Z-0336-2016	—	terminated	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
Oct 29, 2015	Z-0335-2016	—	terminated	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
Oct 29, 2015	Z-0337-2016	—	terminated	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
Oct 29, 2015	Z-0326-2016	—	terminated	Ultrafiltration (UF) Volume software error inaccurate fluid removal
May 14, 2014	Z-1859-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1857-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1855-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1860-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1861-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1856-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1858-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
May 14, 2014	Z-1854-2014	—	terminated	SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
Jan 24, 2014	Z-1073-2014	—	terminated	Mislabeled product.
Mar 18, 2013	Z-1214-2013	—	terminated	Product may be mislabeled.
Dec 14, 2011	Z-0826-2012	—	terminated	Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System
Jul 27, 2007	Z-1228-2007	—	terminated	Potential for dialysate leaks from the cartridge during treatment.
Apr 14, 2004	Z-1069-04	—	terminated	Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate
Apr 14, 2004	Z-1070-04	—	terminated	Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate
Apr 14, 2004	Z-1071-04	—	terminated	Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate