Z-0177-2015 Class II Terminated
FDA device recall Z-0177-2015 was initiated by St Jude Medical on Oct 14, 2014 and is designated Class II. 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… The recall status is terminated (terminated Dec 10, 2014). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 12, 2014
- Initiation Date
- Oct 14, 2014
- Termination Date
- Dec 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
Product Description
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
Distribution Pattern
US Distribution including the states of CA, GA, NJ, NY, OR and PA.
Code Information
Batch # 4671318
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0177-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026