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U.S. Department of Health and Human Services

Class 2 Device Recall IcePearl" Cryoablation Needles

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 Class 2 Device Recall IcePearl" Cryoablation Needlessee related information
Date Initiated by FirmNovember 18, 2020
Create DateDecember 22, 2020
Recall Status1 Open3, Classified
Recall NumberZ-0661-2021
Recall Event ID 86777
510(K)NumberK152133 
Product Classification Unit, cryosurgical, accessories - Product Code GEH
ProductIcePearl" 2.1 CX Cryoablation Needle
Code Information UPN: FPRPR3603  UDIs: 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010, 7290104831010  Batch Numbers: U0902, U0786, U0646, U0558, U0041, T0269, T0137, T0138, T0056, T0025, A7015, A6929, A6908, A6723, A1564, A1521, A1249
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 Commerce86 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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