Z-0177-2015Class II

St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353

Name: Z-0177-2015 St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Creator: St Jude Medical
Published: 2014-10-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-10-14 / Terminated / root cause: labeling and UDI

FDA source

St Jude Medical began a recall of St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 on 2014-10-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0177-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-14
Posted: 2014-11-06
Terminated: 2014-12-10
Recalling firm: Abbott Medical
Product: St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Product code: DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
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
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: St. Jude Medical sent an "Urgent Medical Device Recall Notice" letter dated October 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Advised customers to discontinue the use of the recalled device and inform them that a St. Jude Medical sales representative will contact them in the near future to facilitate removal and reconciliation of the recalled device. For questions they can contact their St. Jude Medical Sales Representative. For further questions please call (651) 756-2295.
Quantity in commerce: 26
Distribution: US Distribution including the states of CA, GA, NJ, NY, OR and PA.
Product codes and lots: Batch # 4671318

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0177-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0177-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-12	2014-11-06

Product code DRF

K894500Class IIDaig Electrophysiology CatheterDaig Corp. / cleared 1989-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)