St Jude Medical Inc: Medical Device Recall in 2013 - (Recall #: Z-0617-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minnetonka, MN 55343 Indicated for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.

Product Classification:

Class III

Date Initiated: March 28, 2012

Date Posted: January 9, 2013

Recall Number: Z-0617-2013

Event ID: 63855

Reason for Recall:

St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged as a 180 degree curve style introducer instead of a 90 degree curve style introducer as indicated on the labeling.

Status: Terminated

Product Quantity: 26

Code Information:

Model no. 406586 Batch no. 3619533

Distribution Pattern:

US Distribution only including the states of FL, KY and OK.

Voluntary or Mandated:

Voluntary: Firm initiated