C315-HIS Delivery Catheter — Class II medical device recall Z-0173-2022
Ongoing recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2021-11-03. Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass
| Recall number | Z-0173-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2021-09-09 |
| Classified | 2021-10-22 |
| Reported by FDA | 2021-11-03 |
| Countries outside the US | AU, CN, DE, HK, ID, MY, NL, SG, TW |
| Quantity | 591 units |
| UPC / GTIN / UDI-DI | 00763000160180 |
| Lot numbers | 0010567341, 10568899, 10568900 |
| Model numbers | C315HIS02 |
Product
C315-HIS Delivery Catheter
Reason for recall
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0173-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.