Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF… recallZ-0617-2013 · St Jude Medical Inc · initiated Mar 28, 2012
Class III Terminated All recalls posted in December 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St Jude Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
St Jude Medical hand delivered the" Product Recall" letter dated March 27, 2012, to the affected customers on April 5, 2012, and March 28, 2012. The letter identified the product, the problem and the action needed to be taken by the customer. The returned devices and those not distributed were quarantined at the SJM Minnetonka distribution center until their destruction. Customers were requested to to complete and return the reconciliation form. Further questions please call (651) 756-6526
Recall details
- Recall number
- Z-0617-2013
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Mar 28, 2012
- Posted by the FDA
- Dec 28, 2012
- Recalling firm
- St Jude Medical Inc
- Quantity
- 26
- Product code
- DYB
- FDA submissions
- K964518
- Distribution
- US Distribution only including the states of FL, KY and OK.
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.
Code information (models, lots, serial numbers)
Model no. 406586 Batch no. 3619533
Other devices under the same FDA submission
5 devices cleared under K964518 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Fast-Cath™ 406842St. Jude Medical, Inc. · INTRODUCER, CATHETER3 reports
- Fast-Cath™ 407436St. Jude Medical, Inc. · INTRODUCER, CATHETER2 reports
- Fast-Cath™ 406885St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
- Fast-Cath™ 406965St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
- Fast-Cath™ 406851St. Jude Medical, Inc. · INTRODUCER, CATHETER1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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