Intra-aortic Balloon Balloon Pump
- Recalling firm
- Getinge Australia Pty Ltd (NZ)
- Product
- Intra-Aortic Balloon Balloon pump. [Device]. Model: Product: Intra-Aortic Balloon CS100 IABP, CS300 IABP
- Reason
- The manufacturer has become aware of instances where the device did not provide the expected runtime during some portable IABP uses CS100/CS300 devices. The manufacturer recently completed additional testing on the CS100/CS300 batteries and identified the battery runtime and cycle specifications contained in the devices' Instructions for Use (IFU) were incorrect and need to be updated. No other CS100/CS300 IABP performance deficiencies were identified.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-07-28
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/a5fb06cb-fff3-48b1-9e70-b442343f96e1