Z-0617-2013 Class III Terminated
FDA device recall Z-0617-2013 was initiated by St Jude Medical Inc on Mar 28, 2012 and is designated Class III. 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… The recall status is terminated (terminated Jul 12, 2013). Affected quantity: 26.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 9, 2013
- Initiation Date
- Mar 28, 2012
- Termination Date
- Jul 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26
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.
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.
Distribution Pattern
US Distribution only including the states of FL, KY and OK.
Code Information
Model no. 406586 Batch no. 3619533
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0617-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026