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U.S. Department of Health and Human Services

Class 2 Device Recall IceSeed" Cryoablation Needles

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  Class 2 Device Recall IceSeed" Cryoablation Needles see related information
Date Initiated by Firm November 18, 2020
Create Date December 22, 2020
Recall Status1 Open3, Classified
Recall Number Z-0680-2021
Recall Event ID 86777
510(K)Number K051052  
Product Classification Unit, cryosurgical, accessories - Product Code GEH
Product IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿
Code Information UPN: FPRPR3194  UDIs: 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280, 7290104830280  Batch Numbers: U1368, U1367, U1040, U0396, U0380, U0375, U0374, U0242, U0241, T0532, T0533, T0531, T0530, T0444, T0443, T0442, T0353, T0354, T0262, T0263, A6720, A6719, A6698, A6697, A2049, A2050, A1999, A1998, A1990, A1991, A1891, A1890, A1844, A1845, A1690, A1562, A1563, A1533, A1326, A1325, A1197, A1196, A1041, A1040, A1008, A1007, A0955, A0954
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 1,526 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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