St Jude Medical: Medical Device Recall in 2014 - (Recall #: Z-0177-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 14, 2014

Date Posted: November 12, 2014

Recall Number: Z-0177-2015

Event ID: 69512

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

Status: Terminated

Product Quantity: 26

Code Information:

Batch # 4671318

Distribution Pattern:

US Distribution including the states of CA, GA, NJ, NY, OR and PA.

Voluntary or Mandated:

Voluntary: Firm initiated