Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:21730
Brand Name:Balloon pump
Model:
Affected:CS100 and CS300 Intraortic Balloon Pumps, also applies to any System 98 or System 98XT IABP which was converted to a CS100i or CS300 IABP.
Software version:
Recalling Organisation:Maquet Australia Pty Ltd (NZ)
12G Andromeda Cres East Tamaki
Auckland 2013
Contact Information:021 874 882
Manufacturer:Datascope Corporation
Issue:The manufacturer has received complaints involving the CS100/CS100i and CS300 IABPs regarding the following issues:
" False blood detection alarm, and
" The ingress of fluids into the IABP affecting various electronic circuit boards.
Either issue could potentially prevent initiation or continuation of therapy.
Recall action type:Correction
Recall action:Manufacturer to issue advice regarding use
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:27/7/2017
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