NxStage Medical, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0336-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

NxStage System One S Cycler - Model no. NX1000-3-A (OUS). For home hemodialysis.

Product Classification:

Class II

Date Initiated: October 29, 2015

Date Posted: December 2, 2015

Recall Number: Z-0336-2016

Event ID: 72554

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

Status: Terminated

Product Quantity: 133 units

Code Information:

Software version 4.9 and 4.10

Distribution Pattern:

Worldwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated