FDA Device recall Z-0173-2022
C315-HIS Delivery Catheter
- FDA Device
- Class II
- ongoing
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class II recall of C315-HIS Delivery Catheter by Medtronic Cardiac Rhythm And Heart Failure Crhf, citing medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0173-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-09-09 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Cardiac Rhythm And Heart Failure Crhf |
| Distribution | n/a |
Product
C315-HIS Delivery Catheter
Reason
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Identifiers
| code_info | GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 105…GTIN: 00763000160180; Model: C315HIS02 (Serial Number/Lot Number: 0010567341), C315HIS03 (Serial Number/Lot Number: 10568899), and C315HIS04 (Serial Number/Lot Number: 10568900) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0173-2022%22
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