Recall Z-1685-2024 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
| Date | May 10, 2024 (initiated Mar 21, 2024) |
| Status | Open, Classified |
| Reason | An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. |
| Root cause | Under Investigation by firm |
| Action | Boston Scientific issued an Urgent Medical Device Removal notice to its consignees on 03/21/2024 via overnight delivery. The notice explained the issue, the potential risk, and requested the removal of the affected products. Distributors were directed to notify their consignees. |
| Quantity | 8579 catheters |
| Distribution | Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter Boston Scientific Corporation, Oct 29, 2015 |