| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00848-1 |
| Product Name/Description |
4.0mm x15mm Small Peripheral Cutting Balloon (Monorail & Over-the-Wire ) Microsurgical Dilatation Device (used for Percutaneous Transluminal Angioplasty of obstructive lesions in peripheral vessels) and 4.00mm x15mm Flextome Cutting Balloon (Monorail & Over-the-Wire) Microsurgical Dilatation Device (used in patients with coronary vessel disease)
Multiple catalogue numbers and lot numbers
Expiration Date Range: 16-Nov-2015 to 03-Jun-2016
ARTG Numbers: 168036 and 169861 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
9/08/2013 |
| Responsible Entity |
|
| Reason/Issue |
Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the device which may result in damage to the device. |
| Recall Action |
Recall |
| Recall Action Instructions |
Customers are asked to segregate the affected product immediately from their inventory and return it to Boston Scientific. |
| Contact Information |
02 8063 8340 - Boston Scientific Quality Assurance |