Device product
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.
Z-0617-2013
Product summary
- Event
- Event 63855
- Status
- Terminated
- Classification
- Class III
- Quantity
- 26
- Official record key
device-enforcement:Z-0617-2013
Official wording
Reason: 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.
Code information: Model no. 406586 Batch no. 3619533
Distribution pattern: US Distribution only including the states of FL, KY and OK.
Derived failure modes
-
Unknown
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.