| | Class 2 Device Recall IcePearl" Cryoablation Needles |  |
| Date Initiated by Firm | November 18, 2020 |
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| Create Date | December 22, 2020 |
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| Recall Status1 |
Completed |
| Recall Number | Z-0683-2021 |
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| Recall Event ID |
86777 |
| 510(K)Number | K152133 |
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| Product Classification |
Unit, cryosurgical, accessories - Product Code GEH
|
| Product | IcePearl" 2.1 CX Prostate Cryoablation Kit |
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| Code Information |
UPN: FPRPR3606 UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041 Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171 |
| FEI Number |
3002095335
|
Recalling Firm/
Manufacturer |
Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
|
| For Additional Information Contact | Nicole Pshon
763-494-1700 |
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Manufacturer Reason
for Recall | Complaint trend regarding needle shaft gas leaks. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Customers will be sent a product advisory via overnight mail. |
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| Quantity in Commerce | 215 units |
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| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = GEH
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