St — Class II medical device recall Z-0177-2015
Terminated recall by St Jude Medical, reported 2014-11-12, distributed in CA, GA, NJ, NY, OR, PA. St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed
| Recall number | Z-0177-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical, Saint Paul, MN, United States |
| Recall initiated | 2014-10-14 |
| Classified | 2014-11-06 |
| Reported by FDA | 2014-11-12 |
| Terminated | 2014-12-10 |
| Distributed | CA, GA, NJ, NY, OR, PA |
| Quantity | 26 |
| Lot numbers | 4671318 |
| Model numbers | 401353 |
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Reason for recall
St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
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-0177-2015. 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.