| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01346-1 |
| Product Name/Description |
SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK
Product Code/Part Number: D684-00-0576-01
Lot Number: 3000043375
ARTG Number: 139645 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
6/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
During internal pressure (leak) testing of the affected product, failures related to the tip seal leak were identified by Getinge. This issue at the catheter tip seal could potentially cause a leak in the balloon and may lead to an interruption of therapy resulting in the need to replace the defective IABC with a new catheter. Such occurrences could cause momentary haemodynamic instability in a patient, or potential complications related to vessel bleeding related to replacement of the IAB catheter.
To date, there have been no reports of serious injury. |
| Recall Action |
Recall |
| Recall Action Instructions |
Getinge is advising users to quarantine any remaining stocks of the affected product for return.
This action has been reviewed and is considered complete in accordance with the requirements of the URPTG. |
| Contact Information |
1800 438 464 - Getinge Customer Service |