Balloon Pump

Recalling firm
Getinge Australia Pty Ltd (NZ)
Product
Balloon pump. [Device]. Model: CS100/CS300 batteries
Reason
The manufacturer has completed additional testing of the CS100/CS300 batteries and determined that the battery runtime and cycle specifications stated in the Instructions for Use (IFU) require updating. No performance deficiencies were identified for the CS100/CS300 intra-aortic balloon pump (IABP) devices.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-01-30
Status
Ongoing
Distribution
New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/0c575c10-3ffc-49c5-b3b6-f221774af90c