Boston Scientific Corporation Recall 90735
Description: Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Boston Scientific Corporation Recall 90735 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1582-2022 |
| Event ID | 90735 |
| Event Description | Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 |
| Product Type | Devices |
| Distribution | International distribution in the countries of Greece, France, Germany, Italy, Brazil and South Korea |
| Quantity | 94 devices |
| Recall Reason | The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter. |
| Device Classification | 20220831 |
| Device Code Info | UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18 |
| Center Classification Date | 20220825 |
| Recall Initiation Date | 20220809 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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