Recall of Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hospira Pty Limited.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
  • Reason
    There may be a delay in delivery of pain medication when using epidural mode with patient bolus on sapphire multi-therapy & sapphire epidural pumps that have software v11.00 or lower installed. on these pumps, this delay can only occur if the user attempts to start the infusion without first opening the clamp.Under specific conditions, if a treatment that is programmed in epidural mode is started by the user without the user opening the clamp, the pump may not detect an occlusion. this resultant potential delay in therapy may happen, if, and only if, all of the following conditions occur concurrently:a. the clamp is left closed at the “start” of the treatment; andb. the treatment is set at epidural mode; andc. the programmed treatment is set to “bolus only”, i.E., the basal rate=0;this specific combination of conditions may only occur with pumps that have software v11.00 or lower. there is a potential risk of delay in the pain therapy.
  • Action
    Hospira is advising users to upgrade software on the affected devices. Additionally, Hospira is reminding users to ensure the clamp is open when starting an infusion. This action has been closed-out on 06/09/2016.


  • Model / Serial
    Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and belowHospira List Numbers:163113601 and 163123601Q Core Number (on pump): 15031-000-0001 and 15032-000-0001ARTG Number: 201499
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source