FDA Device recall Z-0617-2013
Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minn…
- FDA Device
- Class III
- terminated
- Published 2013-01-09
On 2013-01-09 the FDA classified a Class III recall of Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, Sterile EO, Rx only, St. Jude Medical, 14901 DeVeau Place, Minn… by St Jude Medical, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0617-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-03-28 |
| Published | 2013-01-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | St Jude Medical |
| Distribution | FL, KY, OK |
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.
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.
Identifiers
| code_info | Model no. 406586 Batch no. 3619533 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0617-2013%22
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