Device Recall Transseptal Sheath Introducer Kits

Catalog Numbers: XD252500, XD252501, XD252502, XD252503, XD252504, XD252505, XD252506, XD252507, XD252508, XD252509, TF8-38-62-5, TF8-38-62-B1, FCL-127-00, FCL-127-01, FCL-127-02, FCL-127-03, FCL-127-04, FCL-127-05, FCL-127-06, FCL-127-07, FCL-127-08 and FCL-127-09; and  Lot Numbers: 25346, S20361, S20361X1, S20362, S20362X1, S20452, S20501, S20501X1, S20502, S20502X1, S20503, S20504, S20971, S20980, S21218, S21218X1, S21244, S21270, S21270X1, S21271, S21272, S21273, S21278, S21571, S21828, S21903, S21904, S21905, S21906, S21940, S21973, S22005, S22019, S22020, S22057, S22088, S22094, S22095, S22096, S22107, S22108, S22235, S22236, S22237, S22237X1, S22238, S22239, S22240, S22241, S22242, S22243, S22246, S22495, S22496, S22497, S22498, S22598, S22613, S22614, S22670, S22677, S22739, S22739X1, S22754, S22871, S22880, S22890, S22908, S22939, S22950, S23012, S23163, S23380, S23400, S23401, S23449, S23454, S24213, S24759, S25171, S25393, S25536, S25618 S25647, S26047, S26129, S26480, S26969, S26970, S27089, S27367, S27368, S27369, S27466, S27587, S27631, S27632, S27647, S27767, S27768, S27772, S27953, S27966, S28055, S28539, S28555, S28587, S28796, S29034, S29035, S29527, S29659, S29660, S29934, S30137, S30427, S30428 and S30519.

Cardiovascular Devices

2

No

Worldwide Distribution -- United States (CA, MA and NJ), Canada, Germany, and the United Kingdom.

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.