Boston Scientific Corporation Recall 94240
Description: Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
Boston Scientific Corporation Recall 94240 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1649-2024 |
| Event ID | 94240 |
| Event Description | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter |
| Product Type | Devices |
| Distribution | Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions. |
| Quantity | 25617 catheters |
| Recall 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. |
| Device Classification | 20240522 |
| Device Code Info | UDI/DI 08714729187806, Batch Numbers: 60432320, 60447145, 60468840, 60491659, 60515603, 60523996, 60438675, 60459197, 60475371, 60495554, 60522591, 60533644, 60440974, 60467093, 60483661, 60504885, 60522595, 60536197 |
| Center Classification Date | 20240510 |
| Recall Initiation Date | 20240321 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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