Boston Scientific Corporation Recall 92785
Description: Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Boston Scientific Corporation Recall 92785 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0015-2024 |
| Event ID | 92785 |
| Event Description | Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Indiana. |
| Quantity | 1086 units |
| Recall Reason | Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape. |
| Device Classification | 20231011 |
| Device Code Info | GTIN 08714729283508, Lot/Batch Numbers: 26277195, 26891778, 25715235, 25715236, 25761247, 25761248, 26059690, 26277194, 26599706, 27170548, 27444248, 27516585, 28057178, 28584686, 28595475, 28811944 |
| Center Classification Date | 20231003 |
| Recall Initiation Date | 20230727 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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