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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