Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88688
Description: C315-HIS Delivery Catheter
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 88688 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0173-2022 |
| Event ID | 88688 |
| Event Description | C315-HIS Delivery Catheter |
| Product Type | Devices |
| Distribution | Distributed internationally to Australia, Brunei Darussalam, China, Germany, Hong Kong, Indonesia, Malaysia, Netherlands, Singapore, and Taiwan. |
| Quantity | 591 units |
| Recall Reason | Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. |
| Device Classification | 20211103 |
| Device Code Info | GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900) |
| Center Classification Date | 20211022 |
| Recall Initiation Date | 20210909 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Letter |
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