FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
FDA Recall Z-0535-2007 · Posted 2007-03-01
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Recalling FirmSt. Jude Medical / Daig Division
Recall StatusTerminated
Product CodeDYB
Date Initiated2006-10-05
Date Terminated2007-05-25
Product Quantity40 Units
Reason for Recall
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.
Firm Action
The affected customers were notified on 10/5/06 by letter.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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