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NxStage Medical Recalls
31 recalls on record · May 8, 2013 to June 4, 2025 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 4, 2025Medical DevicesFDA
NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF
Hazard: 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.
June 26, 2024Medical DevicesFDA
NxStage Medical Inc recalls NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-
Hazard: 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.
December 25, 2019Medical DevicesFDA
NxStage Medical, Inc. recalls Low Volume Cartridge IFU (SKU CAR-125-B) used with the following devices: 1) NxStage One, Model NX1000-1; 2) NxStage
Hazard: 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.
June 12, 2019Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal rep
Hazard: Certain lots were mislabeled with incorrect product number.
June 12, 2019Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product NxStage PureFlow B Solution is indicated for use with r
Hazard: Certain lots were mislabeled with incorrect product number.
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-RFP-456, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicate
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-RFP-454, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicate
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-406, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated fo
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated fo
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-403, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-402, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated fo
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-401, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated fo
Hazard: 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
December 5, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. NxStage PureFlow B Solution is indicated
Hazard: 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
August 22, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Express Fluid Warmer (FW-300, FW-300-A, FW-300-WW, FW-301, FW-301-A) Product Usage: The NxStage Express Flui
Hazard: 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.
March 28, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Hazard: 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.
March 7, 2018Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030,
Hazard: 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.
December 2, 2015Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Hazard: 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
December 2, 2015Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.
Hazard: 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
December 2, 2015Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.
Hazard: 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
December 2, 2015Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5-A
Hazard: Ultrafiltration (UF) Volume software error inaccurate fluid removal
December 2, 2015Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage System One S Cycler (High Permeability Hemodialysis System) Model no. NX1000-5
Hazard: Ultrafiltration (UF) Volume software error inaccurate fluid removal
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-407 Lactate 40, Potassium 1, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-306 Lactate 45, Potassium 2, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-305 Lactate 45, Potassium 1, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-304 Lactate 45, Potassium 2, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-303 Lactate 45, Potassium 1, Sodium 1
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-302 Lactate , 40, Potassium 1, Sodium
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
July 2, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-301 Lactate 45, Potassium 1, Sodium
Hazard: SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
March 5, 2014Medical DevicesFDA
NxStage Medical, Inc. recalls NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L
Hazard: Mislabeled product.