Boston Scientific Corporation recalls Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoabl

Hazard / Issue

The needle surface deteriorated due to unexpected electrolysis during procedure.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: UPN: FPRPR3602, GTIN: 7290104831003, Batch: A0754, A0755, A0758, A0759, A0770, A0771, A0782, A0783, A0788, A0789, A0794, A0795, A0803, A0804, A0827, A0828, A0833, A0834, A0844, A0845, A0856, A0857, A0871, A0872, A0880, A0881, A0894, A0895, A0905, A0906, A0907, A0908, A0922, A0923, A0925, A0926, A0930, A0931, A0939, A0940, A0941, A0942, A0952, A0953, A0956, A0957, A0958, A0959, A0972, A0973, A0974, A0975, A0996, A0997, A0999, A1000, A1010, A1011, A1017, A1018, A1034, A1035, A1036, A1037, A1042, A1043, A1045, A1073, A1074, A1076, A1077, A1088, A1089, A1093, A1094, A1100, A1101, A1127, A1128, A1172, A1173, A1129, A1130, A1131, A1132, A1135, A1136, A1214, A1215, A1228, A1229, A1243, A1244, A1246, A1247, A1258, A1259, A1266, A1267, A1659, A1660, A1661, A1662, A1670, A1671, A1676, A1677, A1696, A1697, A1698, A1699, A1702, A1703, A1704, A1705, A1708, A1709, A1736, A1737, A1740, A1741, A1742, A1743, A1269, A1270, A1289, A1290, A1315, A1316, A1330, A1331, A1332, A1333, A1338, A1339, A1345, A1346, A1350, A1351, A1352, A1353, A1354, A1355, A1357, A1358, A1359, A1360, A1361, A1362, A1365, A1366, A1371, A1372, A1375, A1376, A1380, A1381, A1383, A1384, A1385, A1386, A1387, A1388, A1389, A1390, A1397, A1398, A1406, A1407, A1414, A1415, A1425, A1426, A1431, A1432, A1445, A1446, A1452, A1453, A1462, A1463, A1467, A1468, A1469, A1470, A1491, A1492, A1493, A1494, A1503, A1504, A1536, A1537, A1542, A1543, A1557, A1558, A1570, A1571, A1584, A1585, A1594, A1595, A1597, A1598, X6924, A1608, A1609, A1622, A1623, A1624, A1625, A1630, A1631, A1637, A1638, A1641, A1642, A1744, A1745, A1751, A1752, A1770, A1771, A1777, A1778, A1783, A1784, A1787, A1788, A1789, A1790, A1795, A1796, A1805, A1806, A1814, A1815, A1826, A1827, A1835, A1836, A1840, A1841, A1842, A1843, A1849, A1850, A1851, A1852, A1855, A1856, A1859, A1860, A1862, A1863, A1867, A1868, A1881, A1882, A1887, A1888, A1899, A1900, A1903, A1904, A1907, A1908, A1913, A1914, A1916, A1917, A1918, A1919, A1920, A1921, A1938, A1939, A1940, A1941, A1931, A1932, A1952, A1953, A1957, A1958, A1963, A1964, A1969, A1970, A1980, A1981, A1992, A1993, A1995, A1996, A2004, A2005, A2014, A2015, A2027, A2028, A2031, A2032, A2046, A2047, A2051, A2052, A2056, A2057, A2084, A2085, A2111, A2112, A2125, A2126, A2134, A2135, A2139, A2140, A6636, A6637, A6638, A6639, A6651, A6652, A6674, A6675, A6683, A6684, A6703, A6704, A6724, A6725, A6728, A6759, A6760, A6763, A6764, A6765, A6766, A6783, A6784, A6803, A6804, A6805, A6806, A6841, A6842, A6850, A6851, A6858, A6859, A6862, A6863, A6868, A6869, A6874, A6875, A6876, A6877, A6881, A6882, A6887, A6888, A6894, A6895, A6904, A6905, A6909, A6910, A6919, A6920, A6921, A6922, A6934, A6935, A6936, A6937, A6938, A6939, A6946, A6947, A6954, A6955, A6959, A6973, A6974, A6996, A6997, A7023, A7024, A7041, A7047, A7054, A7050, A7051, A7055, A7056, A7057, A7058, A7059, A7060, A7096, A7097, A7080, A7081, A7086, A7087, A7089, A7090, A7092, A7093, A7094, A7095, A7098, A7099, A7107, A7108, A7109, A7128, A7129, A7130, A7131, A7140, A7141, A7142, A7144, A7146, A7147, A7151, A7152, A7177, A7178, A7189, A7190, A7191, A7192, A7199, A7200, A7207, A7208, A7209, A7210, A7221, A7222, A7229, A7230, T0004, T0007, T0038, T0039, T0046, T0047, T0048, T0049, T0076, T0077, T0082, T0083, T0085, T0086, T0087, T0088, T0089, T0090, T0095, T0096, T0097, T0098, T0105, T0106, T0107, T0108, T0109, T0110, T0113, T0114, T0120, T0121, T0122, T0124, T0139, T0140, T0406, T0147, T0148, T0159, T0160, T0164, T0165, T0168, T0169, T0174, T0175, T0176, T0177, T0183, T0184, T0185, T0186, T0190, T0191, T0194, T0195, T0199, T0200, T0206, T0207, T0208, T0209, T0217, T0218, T0220, T0221, T0225, T0226, T0227, T0228, T0229, T0230, T0231, T0232, T0239, T0240, T0241, T0242, T0243, T0244, T0255, T0256, T0264, T0265, T0276, T0277, T0279, T0280, T0287, T0288, T0289, T0290, T0291, T0292, T0316, T0309, T0310, T0320, T0321, T0322, T0323, T0331, T0332, T0334, T0335, T0336, T0337, T0338, T0343, T0344, T0376, T0377, T0382, T0396, T0398, T0399, T0404, T0405, T0420, T0421, T0422, T0423, T0424, T0425, T0426, T0427, T0435, T0436, T0446, T0447, T0459, T0460, T0471, T0472, T0477, T0478, T0479, T0480, T0481, T0482, T0494, T0495, T0496, T0497, T0500, T0501, T0505, T0506, T0508, T0509, T0510, T0513, T0514, T0516, T0517, T0518, T0519, T0525, T0526, T0534, T0535, T0543, T0545, T0548, T0549, T0553, T0554, T0563, T0564, T0568, T0569, T0573, T0574, T0575, T0576, T0579, T0580, T0581, T0582, T0585, T0586, T0612, T0613, T0622, T0623, T0624, T0625, T0626, T0627, T0628, T0629, T0630, T0631, T0637, T0638, T0639, T0640, T0641, T0642, T0643, T0644, T0645, T0646, T0661, T0662, T0708, T0709, T0684, T0685, T0727, T0728, T0729, T0730, T0714, T0717, T0715, T0716, T0733, T0734, T0737, T0781, T0738, T0739, T0740, T0742, T0741, T0743, T0744, T0782, T0808, T0809, T0810, T0811, T0812, U0022, U0023, U0024, U0025, U0026, U0048, U0049, U0055, U0056, U0076, U0077, U0078, U0079, U0080, U0081, U0090, U0096, U0097, U0100, U0101, U0104, U0105, U0106, U0107, U0110, U0111, U0138, U0139, U0140, U0141, U0142, U0143, U0144, U0145, U0162, U0163, U0170, U0171, U0190, U0191