Fast-Cath Transseptal Guiding Introducer — Class III medical device recall Z-0617-2013
Terminated recall by St Jude Medical Inc, reported 2013-01-09, distributed in FL, KY, OK. St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which was packaged a
| Recall number | Z-0617-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical Inc, Saint Paul, MN, United States |
| Recall initiated | 2012-03-28 |
| Classified | 2012-12-28 |
| Reported by FDA | 2013-01-09 |
| Terminated | 2013-07-12 |
| Distributed | FL, KY, OK |
| Quantity | 26 |
| Reason classes | labeling |
| Lot numbers | 3619533 |
| Model numbers | 406586 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0617-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.