Boston Scientific Corporation 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Boston Scientific Corporation is recalling Ablation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription Only Galil Medicals due to The needle surface deteriorated due to unexpected electrolysis during procedure.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The needle surface deteriorated due to unexpected electrolysis during procedure.
Recommended Action
Per FDA guidance
Boston Scientific sent a letter dated 06/04/2020 and titled, "Urgent Medical Device Removal - Immediate Action Required" to customers regarding the IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The firm initiated a removal of specific lots/batches of IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The letter states that further distribution or use of any remaining product affected by the removal should cease immediately. Customers should verify the product lot/batch number to identify whether any product within their inventory is affected. If they have affected product in their inventory customers should respond and follow the instructions on the verification form. Customers must complete the Reply Verification Tracking Form and returned even if you do not have any of the units from the recalled lot/batch and email or fax your Reply Verification Tracking Form(s) immediately to get a Returned Goods Authorization Number (RGA #) before you return any product. Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Package/Ship the Recalled Product. Seal the box, and return to: Boston Scientific Corporation, US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: Replacement product will be provided once affected product has been received by Boston Scientific Distributors should forward the notification to customers. Facilities that have sent products to another hospital within their network, should ensure that the notification is forwarded to them. Customers should contact their local sales representatives; email: BSCFieldActionCenter@bsci.com or can contact Sr. Regulatory Affairs Specialist at 508-683-40 or email: clara.johnson@bsci.com regarding any questions associated with the notification. BSCFieldActionCenter@bsci.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026