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.

Recall Insight

This FDA Devices action (record #Z-0617-2013) was formally reported on January 9, 2013, with the manufacturer initiating the action on March 28, 2012. It is classified under Low severity (Class III), with a current status of Terminated. St Jude Medical Inc is listed as the recalling firm, operating out of Saint Paul, MN. Federal records indicate 26 units are affected.

The documented reason for this recall is: 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 label… Distribution data in the federal record shows the product reached: US Distribution only including the states of FL, KY and OK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 13 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.