Lawrence, MA, United States
NxStage Medical, Inc. recalls
8 recalls recorded since 2018, most recently on 28 April 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)2
Terminated or completed6
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 28 April 2025
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1864-2025
- NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
Ongoing Class II Medical devices
- Recall started
- 14 May 2024
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2160-2024
- NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
Terminated Class II Medical devices
- Recall started
- 27 August 2019
- Terminated
- 1 February 2021
- 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.
- Distribution
- AL, AZ, CA, NC & VA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0697-2020
- 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
Terminated Class II Medical devices
- Recall started
- 11 April 2019
- Terminated
- 8 June 2020
- Reason
- Certain lots were mislabeled with incorrect product number.
- Distribution
- US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1707-2019, Z-1706-2019
- NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
- NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Terminated Class II Medical devices
- Recall started
- 17 October 2018
- Terminated
- 26 August 2020
- Reason
- 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
- Distribution
- US Nationwide Distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0502-2019, Z-0500-2019, Z-0507-2019, Z-0501-2019, Z-0506-2019, Z-0504-2019, Z-0505-2019, Z-0503-2019
- NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodial
- NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemod
- NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemo
- NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodial
- NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemo
- NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodial
- NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodial
- NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodi
Terminated Class II Medical devices
- Recall started
- 11 June 2018
- Terminated
- 28 April 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the countries of Australia, Canada, France, Germany, Italy, Kuwait, Netherlands, Saudi Arabia, Spain, Sweden, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2793-2018
- NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm therapy fluids prior to administrati
Terminated Class II Medical devices
- Recall started
- 29 January 2018
- Terminated
- 3 April 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0811-2018
- NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6)
Terminated Class II Medical devices
- Recall started
- 10 November 2017
- Terminated
- 6 December 2019
- Reason
- 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.
- Distribution
- US nationwide distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1132-2018
- NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.