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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled the IcePearl 2.0 CX 90 Cryoablation Needle, a prescription medical device used for cryoablative procedures. A total of 7,536 devices across multiple batch numbers have been recalled due to unexpected electrolysis that caused deterioration of the needle surface during procedures. The affected devices were distributed nationwide across all U.S. states and Canada.
The recalled devices are identified by UPN FPRPR3601 and GTIN 07290104830990, with batch numbers ranging from A0735 through A7194. The recall notice does not specify what actions affected consumers should take or what remedy is available.
Written by software from the official notice below. Not reviewed by a lawyer.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure. Distribution: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada. Quantity: 7536 devices 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.