Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. Intended to allow left heart catheterization procedure to occur through the right atrium.
FDA Recall Z-0815-2010 · Posted 2010-03-04
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Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2010-02-01
Date Terminated2011-01-05
Product Quantity13,973 units
Reason for Recall
Radiopaque tip may fracture
Firm Action
Thomas Medical Products, A GE Healthcare Company, issued an "Urgent Medical Device Correction" letter dated February 1, 2010. Consignees were informed of the affected product then asked to cease distribution, return any product to firm and contact all sub-accounts.
For further information, contact Thomas Medical Products Customer Service at 1-866-446-3003.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.
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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