Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation N

Hazard / Issue

The needle surface deteriorated due to unexpected electrolysis during procedure.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: UPN: FPRPR3601, GTIN: 07290104830990, Batch numbers: A0735, A0736, A0749, A0750, A0798, A0799, A0817, A0818, A0840, A0841, A0874, A0875, A0888, A0889, A0898, A0899, A0945, A0946, A0950, A0951, A0992, A0993, A1003, A1004, A1005, A1006, A1012, A1027, A1028, A1078, A1079, A1090, A1091, A1096, A1097, A1098, A1099, A1111, A1112, A1143, A1144, A1155, A1156, A1168, A1169, A1190, A1191, A1192, A1204, A1205, A1223, A1224, A1232, A1233, A1268, A1271, A1272, A1296, A1297, A1299, A1300, A1302, A1303, A1343, A1344, A1348, A1349, A1369, A1370, A1393, A1394, A1408, A1409, A1417, A1418, A1438, A1439, A1440, A1441, A1454, A1455, A1499, A1500, A1509, A1510, A1516, A1517, A1520, A1538, A1539, A1540, A1541, A1546, A1547, A1553, A1554, A1580, A1581, A1599, A1600, A1603, A1604, A1606, A1617, A1618, A1619, A1649, A1650, A1651, A1652, A1665, A1666, A1674, A1675, A1680, A1681, A1686, A1687, A1734, A1735, A1749, A1750, A1772, A1773, A1797, A1798, A1809, A1810, A1828, A1829, A1853, A1854, A1869, A1870, A1885, A1886, A1893, A1894, A1911, A1912, A1922, A1923, A1926, A1927, A1929, A1930, A1971, A1972, A1982, A1983, A2038, A2039, A2058, A2059, A2107, A2108, A6655, A6656, A6716, A6717, A6733, A6749, A6750, A6794, A6795, A6821, A6822, A6844, A6845, A6852, A6853, A6865, A6866, A6879, A6880, A6884, A6885, A6940, A6941, A6984, A6985, A7067, A7068, A7076, A7077, A7101, A7102, A7111, A7112, A7124, A7125, A7136, A7137, A7161, A7162, A7163, A7164, A7172, A7173, A7175, A7176, A7181, A7182, A7186, A7187, A7193, A7194, T0032, T0033, T0040, T0041, T0061, T0062, T0066, T0067, T0078, T0079, T0130, T0131, T0132, T0133, T0182, T0187, T0202, T0213, T0214, T0233, T0234, T0245, T0246, T0249, T0250, T0251, T0252, T0253, T0254, T0266, T0267, T0293, T0295, T0296, T0297, T0324, T0325, T0345, T0346, T0380, T0381, T0407, T0408, T0409, T0410, T0475, T0476, T0522, T0523, T0537, T0538, T0555, T0556, T0590, T0606, T0607, T0608, T0609, T0610, T0611, T0620, T0621, T0696, T0705, T0706, T0707, T0762, T0763, T0764, T0767, T0768, T0769, T0770, T0771, T0772, T0773, T0777, T0778, T0779, T0784, T0804, T0805, T0806, T0807, U0019, U0020, U0070, U0071, U0072, U0073, U0074, U0075, U0091, U0092, U0112, U0113, U0130, U0131, U0132, U0133, U0134, U0135, U0185, U0186