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

FDA device recall Z-0177-2015 · posted 2014-11-06 · Terminated

Recall details

Recalling firm

St Jude Medical

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

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

DRF

Quantity affected

26

Distribution

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

Date initiated

2014-10-14

Date posted

2014-11-06

Date terminated

2014-12-10

Location

Saint Paul, MN

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