FDA Device recall Z-0177-2015
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- FDA Device
- Class II
- terminated
- Published 2014-11-12
On 2014-11-12 the FDA classified a Class II recall of St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 by St Jude Medical, citing 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 ident….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0177-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-10-14 |
| Published | 2014-11-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | CA, GA, NJ, NY, OR, PA |
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Reason
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
Identifiers
| code_info | Batch # 4671318 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0177-2015%22
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