| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00603-1 |
| Product Name/Description |
CARDIOSAVE Hybrid IABP Intra-Aortic Balloon Pump
CARDIOSAVE Hybrid CARDIOSAVE Hospital Cart CARDIOSAVE Hospital Cart RoHS
Part Numbers: 0997-00-0562 and 0997-001-1179
ARTG Number: 118266
(Getinge Australia Pty Ltd - Circulatory assist unit, pump, balloon) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
29/06/2018 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has received complaints involving the Cardiosave IABPs regarding ingress of fluids into the IABP affecting various electronic circuit boards. This situation would prevent initiation or continuation of therapy.
To date, Getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test.
Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP
This action has been closed out on 20/02/2019 |
| Contact Information |
1800 438 464 - Getinge Australia |