| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00907-1 |
| Product Name/Description |
Inspira Air Balloon Dilation System (Bronchial balloon catheter)
Product Codes: BC0524A, BC0524AZ, BC0724A, BC0724AZ, BC1040A, BC1040AZ, BC1440A and BC1440AZ
ARTG Number: 172707 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
2/09/2013 |
| Responsible Entity |
|
| Reason/Issue |
There is potential for the balloon to not deflate or deflate slowly, which could result in airway obstruction until the balloon is deflated or removed.
Reports of difficulty deflating the balloon during a procedure have been received. In each of these reports, difficulty deflating occurred after the surgeon had pulled against resistance in response to the balloon moving distally during dilation. The force applied to the catheter stretched and narrowed the balloon catheter shaft, causing the balloon to be difficult or impossible to deflate. The potential for this issue to occur exists in all lots and all sizes of the Inspira AIR Balloon Dilation System. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson Medical is updating the information in the instructions for use (IFU) to include the following warnings:
- Should the balloon move distally or proximally in the patient while inflated, it is not be held or pulled against.
- The Inspira Air Balloon Catheter should only be placed in anatomical locations where a portion of the balloon can be continually visualised to ensure access in the unlikely event of deflation difficulty. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical (Option 1) |