| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00349-1 |
| Product Name/Description |
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter Kits
Product codes: IAB-05830-LWS, IAB-05830-U, IAB-05840-LWS, IAB-05840-U, IAB-05850-LWS, IAB-06830-U, IAB-06840-U, IAB-06850-U
Multiple lot numbers
ARTG's 101617, 107249 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/05/2024 |
| Responsible Entity |
|
| Reason/Issue |
A flex-tip defect may be present that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as:
- failure of the intra-aortic balloon to completely inflate over its full length.
- damaged or broken central lumen in the segment contained within the balloon.
- helium loss or blood in the helium pathway.
Possible consequences include a reduction or loss of the hemodynamic support. This would require immediate replacement of the device resulting in delay or temporary interruption of IABP therapy. Therefore, this condition could result in an increased risk of hemodynamic or ischemic complications, including death. Between 05-April-2022 and 05-April-2024, a total of 337 reports of these conditions have been received. This includes reports of 31 injuries and 3 deaths. As reported, two of the three deaths were unrelated to the issue. In the third event, the patient death may or may not have been related. |
| Recall Action |
Product Defect Alert |
| Recall Action Instructions |
Actions to detect this issue:
1. Prior to use, ensure that a back up IAB catheter is available, in the event that a replacement device is needed.
2. Prior to insertion, users should inspect all in-scope IAB catheters for signs of an over-twisted balloon wrap or bent balloon shaft.
3. All in-scope IAB catheters must be inserted under fluoroscopic guidance.
4. Users should be vigilant in responding to pump alarms consistent with the Instructions For Use (IFU) and Users Guide.
5. Users should be vigilant in responding to bedside indicators that an IAB catheter is not performing as expected.
Immediate actions if this issue is identified:
If an IAB catheter is suspected of having this issue, the catheter should be removed and replaced using steps in the IFU. A replacement balloon catheter may be inserted contralaterally or ipsilaterally as determined by the responsible physician after considering the patient’s individual femoral access options and relevant clinical features.
This action has been closed out on 21/08/2024 |
| Contact Information |
1300 360 226 - Teleflex Medical |