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U.S. Department of Health and Human Services

Class 2 Device Recall IceRod" Cryoablation Needles

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  Class 2 Device Recall IceRod" Cryoablation Needles see related information
Date Initiated by Firm November 18, 2020
Create Date December 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-0666-2021
Recall Event ID 86777
510(K)Number K110946  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product IceRod" 1.5 PLUS 90¿ Cryoablation Needle
Code Information UPN: FPRPR3508  UDIs: 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563  Batch Numbers: U1442, U1443, U1435, U1434, U1371, U1372, U1360, U1361, U1020, U1038, U1019, U1017, U1018, U0436, U0392, U0373, U0372, U0327, U0333, U0336, U0334, U0335, U0332, U0329, U0330, U0294, U0289, U0291, U0292, U0290, U0293, U0212, U0213, U0061, U0063, U0044, U0043, U0006, U0007, T0499, T0498, T0342, T0340, T0341, T0328, T0314, T0300, T0298, T0299, T0115, T0116, T0111, T0112, T0068, T0069, T0052, T0053, T0034, T0035, A7228, A7227, A7185, A7184, A7169, A7170, A7171, A7168, A7132, A7133, A7123, A7028, A7029, A7000, A7001, A6971, A6970, A6950, A6951, A6792, A6793, A6778, A6777, A6771, A6772, A6736, A6735, A6699, A6700, A6692, A6693, A6685, A6686, A6665, A6666, A6662, A6661, A6653, A6654, A2115, A2114, A2098, A2097, A2048, A2022, A2009, A2007, A2008, A2006, A1997, A1985, A1984, A1898, A1897, A1830, A1831, A1821, A1822, A1816, A1817, A1808, A1807, A1663, A1664, A1655, A1656, A1593, A1480, A1481, A1456, A1457, A1450, A1451, A1410, A1411, A1367, A1239, A1240, A1237, A1238, A1212, A1213
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information Contact Nicole Pshon
763-494-1700
Manufacturer Reason
for Recall		 Complaint trend regarding needle shaft gas leaks.
FDA Determined
Cause 2		 Under Investigation by firm
Action Customers will be sent a product advisory via overnight mail.
Quantity in Commerce 4,645 units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = GEH and Original Applicant = GALIL MEDICAL LTD.
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