FastCath Transseptal Catheter Introducers with Hemostasis… recallZ-0535-2007 · St. Jude Medical / Daig Division · initiated Oct 5, 2006
Terminated All recalls posted in March 2007
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 / Daig Division 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
Limited number of FastCath Transseptal Catheter Introducers (REF #406850) are susceptible to the irrigation extension tube on the side port becoming disconnected when a pull force is applied.
FDA root cause category: Other
What the company is doing
The affected customers were notified on 10/5/06 by letter.
Recall details
- Recall number
- Z-0535-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 5, 2006
- Posted by the FDA
- Mar 1, 2007
- Recalling firm
- St. Jude Medical / Daig Division
- Quantity
- 40 Units
- Product code
- DYB
- FDA submissions
- K964518
- Distribution
- Nationwide.
Product description
FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
Code information (models, lots, serial numbers)
Lot number 1239904
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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