Type of Product |
Medical Device |
TGA Recall Reference |
RC-2016-RN-00359-1 |
Product Name/Description |
Fetch 2 Aspiration Catheter (used for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature)
Material Numbers (UPN): 109400-002, 109400-003, 109400-004 AND 109400-005
Multiple batch numbers (see attached)
Batch expiration date range: March 2016 to June 2017
ARTG number: 181630 |
Recall Action Level |
Hospital |
Recall Action Classification |
Class I |
Recall Action Commencement Date |
24/03/2016 |
Responsible Entity |
|
Reason/Issue |
Boston Scientific is implementing a recall for all models of the Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the broken shaft from the patient. No serious patient injuries have been reported. |
Recall Action |
Recall |
Recall Action Instructions |
Boston Scientific is advising users to quarantine affected stock and return for credit. This action has been closed-out on 27/01/2017. |
Contact Information |
02 8063 8340 - Boston Scientific |