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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 Needlessee related information
Date Initiated by FirmNovember 18, 2020
Create DateDecember 22, 2020
Recall Status1 Completed
Recall NumberZ-0678-2021
Recall Event ID 86777
510(K)NumberK051052 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIceRod" 1.5 MRI 90 Cryoablation Needle
Code Information UPN: FPRPR3195  UDIs: 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297, 7290104830297  Batch Numbers: U1406, U1407, U1370, U1369, U1041, U1042, U0611, U0610, U0501, U0419, U0447, U0444, U0418, U0322, U0323, U0211, U0243, U0244, U0208, U0209, U0210, U0189, U0188, U0175, U0174, U0031, U0164, U0005, U0004, U0002, U0001, T0786, T0785, T0664, T0665, T0649, T0650, T0562, T0561, T0452, T0451, T0445, T0441, T0440, T0364, T0365, T0361, T0360, T0192, T0193, T0179, T0180, A7213, A6715, A6714, A6712, A6711, A6672, A6673, A2093, A2094, A2036, A2037, A2023, A2024, A2011, A2012, A1986, A1987, A1949, A1948, A1944, A1943, A1925, A1924, A1884, A1883, A1839, A1837, A1838, A1832, A1833, A1758, A1759, A1756, A1757, A1648, A1647, A1572, A1573, A1555, A1556, A1534, A1334, A1321, A1322, A1318, A1319, A1200, A1198, A1201, A1199, A1070, A1071, A1068, A1067, A1002, A1001, A0882, A0883, A0878, A0879, A0737, A0738
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactNicole Pshon
763-494-1700
Manufacturer Reason
for Recall		Complaint trend regarding needle shaft gas leaks.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomers will be sent a product advisory via overnight mail.
Quantity in Commerce3,894 units
DistributionNationwide
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = GEH
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