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U.S. Department of Health and Human Services

Class 2 Device Recall IceRod" iThaw" Cryoablation Needles

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 Class 2 Device Recall IceRod" iThaw" Cryoablation Needlessee related information
Date Initiated by FirmNovember 18, 2020
Create DateDecember 22, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0686-2021
Recall Event ID 86777
510(K)NumberK060390 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIceRod" i-Thaw" Prostate Cryoablation Kit
Code Information UPN: FPRPR3572  UDIs: 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983, 7290104830983  Batch Numbers: U1423, U1422, U1329, U1227, U1091, U1128, U1127, U1090, U0976, U1011, U0919, U0917, U0868, U0869, U0738, U0739, U0403, U0404, U0297, U0296, U0256, U0255, U0217, U0218, U0034, U0176, U0033, U0032, U0016, U0040, U0015, T0759, T0758, T0731, T0651, T0634, T0524, T0507, T0502, T0470, T0429, T0401, T0391, T0372, T0351, T0319, T0306, T0281, T0271, T0247, T0198, T0189, T0161, T0084, T0074, T0008, A7231, A7212, A7206, A7188, A7040, A7018, A6983, A6898, A6886, A6878, A6867, A6864, A6843, A6824, A6787, A6718, A6687, A6671, A6663, A6646, A2138, A2124, A2100, A2099, A2082, A2053, A2013, A2001, A1994, A1975, A1945, A1892, A1761, A1748, A1688, A1685, A1612, A1596, A1519, A1502, A1497, A1479, A1447, A1424, A1405, A1378, A1377, A1356, A1347, A1340, A1320, A1227, A1218, A1202, A1187
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 Commerce947 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.
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) Database510(K)s with Product Code = GEH
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