Recall Z-0815-2010 ยท DYB Introducer, Catheter
Thomas Medical Products Inc
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.
| Date | Mar 4, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | Radiopaque tip may fracture |
| Root cause | Component design/selection |
| 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. |
| Quantity | 13,973 units |
| Distribution | Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040713 | MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM Thomas Medical Products, Inc., Jun 1, 2004 |