Is this your brand? Sign in to claim ownership.
Sign in to claim this brandNxStage Medical, Inc.
United States·US-MF-000026832
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 350, Merrimack Street, Lawrence, MA, United States
- Website
- nxstage.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Paula Rogalski
- EUDAMED SRN
- US-MF-000026832
- FDA FEI Number
- 3003464075
- DUNS Number
- —
Catalogue (288)
Page 1 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VersiHD | NX1000-16-A | FDA UDI | Class II | Active |
| Pureflow Sl - Chassis | NX2000-2-CAN | FDA UDI | Class II | Active |
| Dialysis Priming Set | M4-9440 | FDA UDI | Class II | Active |
| Express Fluid Warmer | FW-301-A | FDA UDI | Class II | Active |
| masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS | D9-2007MGPLB | FDA UDI | Class II | Active |
| Nxstage Cartridge Express | CAR-500 | FDA UDI | Class II | Active |
| ButtonHole SINGLE NEEDLE SET | BH-3006 | FDA UDI | Class II | Unknown |
| Pureflow Sl | NX2000-11-D | FDA UDI | Class II | Active |
| Nxstage Cartridge Express With Speedswap | CAR-535 | FDA UDI | Class II | Active |
| Nxview Touch Screen | NX1274-A | FDA UDI | Class II | Active |
| NxStage PureFlow Solution | RFP-209-A | FDA UDI | Class II | Active |
| Nxstage Cartridge Express | CAR-506 | FDA UDI | Class II | Active |
| NxStage Dosing Calculator | NX1272 | FDA UDI | Class II | Unknown |
| masterguard plus HEMODIALYSIS FISTULA NEEDLE SET | D9-7005MGPLB | FDA UDI | Class II | Active |
| Nxstage System One | NX1000-4 | FDA UDI | Class II | Active |
| Streamline Airless System Set with Locksite Needleless Access Sites | SL-2050M2055 | FDA UDI | Class II | Unknown |
| Nxstage System One | NX1000-5 | FDA UDI | Class II | Active |
| Nxstage System One | NX1000-5-A | FDA UDI | Class II | Active |
| Pureflow Dialysate | RFP-207-CAN | FDA UDI | Class II | Active |
| NxStage PureFlow Solution | RFP-205-A | FDA UDI | Class II | Active |
| ButtonHole with SteriPick NEEDLE SET | BH-7035PE | FDA UDI | Class II | Active |
| Nxstage Cartridge | CAR-124-C | FDA UDI | Class II | Active |
| NxStage PureFlow Solution | RFP-207-WW | FDA UDI | Class II | Active |
| Nxstage Speedswap Express Kit | SSK-535 | FDA UDI | Class II | Active |
| Pureflow Sl | NX2000-11-A | FDA UDI | Class II | Active |
| Nx2me Connected Health Nx2me App | NX1379 | FDA UDI | Class II | Unknown |
| masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS | D9-2016MGP | FDA UDI | Class II | Active |
| Nxview Touch Screen | NX1274 | FDA UDI | Class II | Active |
| masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS | D9-2006MGPLB | FDA UDI | Class II | Active |
| masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS | D9-2005MGPLB | FDA UDI | Class II | Active |
| Nxstage Cartridge Express | CAR-172 | FDA UDI | Class II | Active |
| NxStage PureFlow B Solution | RFP-456 | FDA UDI | Class II | Active |
| Pureflow Sl Kit | NX2000-11 | FDA UDI | Class II | Active |
| Nxstage Cartridge Express | CAR-172-E | FDA UDI | Class II | Active |
| NxStage PureFlow Solution | RFP-209-WW | FDA UDI | Class II | Active |
| Nx2me App | NX3094 | FDA UDI | Class II | Unknown |
| Nxstage System One | NX1000-2 | FDA UDI | Class II | Active |
| Pureflow Sl | NX2000-8 | FDA UDI | Class II | Unknown |
| Nxstage System One | NX1000-3 | FDA UDI | Class II | Active |
| Nxstage Cartridge Express | CAR-170-B | FDA UDI | Class II | Active |
| masterguard plus HEMODIALYSIS FISTULA NEEDLE SET | D9-7015MGP | FDA UDI | Class II | Active |
| ButtonHole with SteriPick NEEDLE SET | BH-7007PE | FDA UDI | Class II | Active |
| Pureflow Dialysate | RFP-204-CAN | FDA UDI | Class II | Active |
| Nxstage Tpe Cartridge | CAR-510-B | FDA UDI | Class II | Unknown |
| ButtonHole with SteriPick TWINPACK+ NEEDLE SET | BH-2006PE | FDA UDI | Class II | Active |
| VersiHD | NX1000-16 | FDA UDI | Class II | Active |
| NxStage PureFlow-B Solution | RFP-401-BB | FDA UDI | Class II | Active |
| ButtonHole with SteriPick NEEDLE SET | BH-7004PE | FDA UDI | Class II | Active |
| masterguard APHERESIS NEEDLE | P9-7006MGLB | FDA UDI | Class II | Active |
| NxStage PureFlow-B Solution | RFP-400-BB | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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.
| 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 |