| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00183-1 |
| Product Name/Description |
AngioJet Ultra 5000A Console - Foot Switch
ARTG Number: 261713 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
8/02/2017 |
| Responsible Entity |
|
| Reason/Issue |
There have been reports regarding the AngioJet Ultra 5000A Console foot switch sticking during use resulting in an undesired continued operation of the device. This situation can occur as a result of the wear and tear of the foot switch, which is normally captured through routine servicing. The most serious consequence from this issue could be the need to abort a procedure if the situation has not been resolved and alternative options are not available. At this stage, there have been no reported patient adverse events as a result of these complaints. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Users are advised that if the situation occurs during use, perform the troubleshooting steps per the operator’s manual. An attempt can be made to manually release the footswitch, or turn the console off to deactivate the catheter. Boston Scientific is advising users who have this issue to discontinue use of the AngioJet Ultra 5000A Console foot switch and to contact their local sales representative. No action is required by users whose device is operating correctly.
This action has been closed out on the 09/10/2018. |
| Contact Information |
1800 676 133 - Boston Scientific |