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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Boston Scientific Corporation: The needle surface deteriorated due to unexpected electrolysis during procedure.

Agency Publication Date: July 21, 2020
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Affected Products

Product: Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

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

Lot Numbers:
numbers
Product: Ablation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

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

Lot Numbers:
A0754
Product: Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN: FPRPR3603, GTIN: 7290104831010, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041

Lot Numbers:
A1564
Product: Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN: FPRPR3604, GTIN: 7290104831027, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041 A1203, A1549, A6734, A6916, A6928, A6931, A7083, T0156, T0166, U0042

Lot Numbers:
A1564
Product: Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN: FPRPR3605, GTIN: 7290104831034, Batch: A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, T0153

Lot Numbers:
A1105
Product: Ablation Galil Technology, IcePearl¿2.1 CX Prostate¿Kit Visual Ice System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN:FPRPR3606, GTIN: 7290104831041, Batch: A1148, A1171, A1248, A1460, A1561, A1582, A1936, A2121, A6702, A6743, A6856, A6925, A7013, A7026, A7088, A7148, T0054, T0136, T0141, T0224, T0236, T0237, T0268, T0437, T0592, U0082, U0027, U0093, U0226, U0227

Lot Numbers:
A1148
Product: Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN:FPRPR3607, GTIN: 7290104831058, Batch: A1194, A1298, A1436, A1569, A1567, A1782, A6754, A6757, A6848, A6849, A6915, T0154, T0163, T0552, U0083

Lot Numbers:
A1194
Product: Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN:FPRPR3608, GTIN: 7290104831065, Batch: A1170, A1583, A1937, A6710, A6744, A6857, A6900, A6913, A6926, A7014, A7027, A7122, T0055, T0144, T0181, T0211, T0212, T0238, T0270, T0816, T0815

Lot Numbers:
A1170
Product: Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084

Lot Numbers:
A0904
Product: Ablation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

UPN: FPRPR3618 , GTIN: 07290104831089, Batch: X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161

Lot Numbers:
X2073

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85815
Status: Resolved
Manufacturer: Boston Scientific Corporation
Manufactured In: United States
Units Affected: 10 products (7536 devices; 18440 devices; 48 devices; 39 devices; 79 devices; 193 devices; 88 devices; 71 devices; 205 devices; 656 devices)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.