IcePearl" 2.1 CX 90 Cryoablation Needle recallZ-0660-2021 · Boston Scientific Corporation · initiated Nov 18, 2020
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaint trend regarding needle shaft gas leaks.
FDA root cause category: Under Investigation by firm
What the company is doing
Customers will be sent a product advisory via overnight mail.
Recall details
- Recall number
- Z-0660-2021
- Status
- Completed
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 8453 units
- Product code
- GEH
- FDA submissions
- K152133
- Distribution
- Nationwide
Product description
IcePearl" 2.1 CX 90 Cryoablation Needle
Code information (models, lots, serial numbers)
Show the full code information (10k characters)
UPN: FPRPR3601 UDIs: 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 7290104830990, 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T0762, T0763, T0771, T0769, T0770, T0773, T0767, T0707, T0705, T0696, T0706, T0607, T0621, T0606, T0620, T0610, T0611, T0608, T0609, T0590, T0556, T0555, T0537, T0538, T0522, T0523, T0475, T0476, T0410, T0409, T0408, T0407, T0380, T0381, T0345, T0346, T0324, T0325, T0297, T0295, T0296, T0293, T0267, T0266, T0249, T0250, T0252, T0253, T0251, T0254, T0245, T0246, T0234, T0233, T0213, T0214, T0202, T0187, T0182, T0132, T0133, T0130, T0131, T0078, T0079, T0067, T0066, T0062, T0061, T0041, T0040, T0032, T0033, A7193, A7194, A7187, A7186, A7182, A7181, A7175, A7176, A7172, A7173, A7164, A7163, A7161, A7162, A7136, A7137, A7125, A7124, A7111, A7112, A7102, A7101, A7077, A7076, A7067, A7068, A6984, A6985, A6940, A6941, A6885, A6884, A6880, A6879, A6865, A6866, A6852, A6853, A6844, A6845, A6821, A6822, A6795, A6794, A6749, A6750, A6733, A6716, A6717, A6655, A6656, A2107, A2108, A2058, A2059, A2038, A2039, A1982, A1983, A1971, A1972, A1929, A1930, A1926, A1927, A1922, A1923, A1912, A1911, A1893, A1894, A1886, A1885, A1870, A1869, A1854, A1853, A1829, A1828, A1810, A1809, A1797, A1798, A1773, A1772, A1750, A1749, A1734, A1735, A1686, A1687, A1680, A1681, A1674, A1675, A1666, A1665, A1651, A1652, A1649, A1650, A1619, A1617, A1618, A1606, A1603, A1604, A1599, A1600, A1581, A1580, A1553, A1554, A1547, A1546, A1541, A1540, A1538, A1539, A1523, A1520, A1517, A1516, A1509, A1510, A1500, A1499, X1482, A1455, A1454, A1440, A1441, A1438, A1439, A1417, A1418, A1408, A1409, A1394, A1393, A1370, A1369, A1349, A1348, A1344, A1343, A1303, A1302, A1299, A1300, A1296, A1297, A1272, A1271, A1268, A1233, A1232, A1223, A1224, A1204, A1205, A1190, A1191, A1169, A1168, A1156, A1155
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IcePearl® 2.1 CX 90° Cryoablation Needle FPRPR3601Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls78 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 86777).
- Z-0657-2021 · CompletedIceFORCE" 2.1 CX 90 Cryoablation Needle
- Z-0658-2021 · CompletedIceFORCE" 2.1 CX Cryoablation Needle
- Z-0659-2021 · CompletedIceFORCE" 2.1 CX L 90 Cryoablation Needle
- Z-0661-2021 · CompletedIcePearl" 2.1 CX Cryoablation Needle
- Z-0662-2021 · CompletedIcePearl" 2.1 CX L 90 Cryoablation Needle
- Z-0663-2021 · CompletedIceRod" 1.5 CX 90 Cryoablation Needle
- Z-0664-2021 · CompletedIceSphere" 1.5 CX 90 Cryoablation Needle
- Z-0665-2021 · CompletedIceRod" 1.5 i-Thaw" Cryoablation Needle
- Z-0666-2021 · CompletedIceRod" 1.5 PLUS 90 Cryoablation Needle
- Z-0667-2021 · CompletedIceRod" 1.5 PLUS Cryoablation Needle
- Z-0668-2021 · CompletedIceRod" 1.5 90 Cryoablation Needle
- Z-0669-2021 · CompletedIceRod" 1.5 Cryoablation Needle
- Z-0670-2021 · CompletedIceSphere" 1.5 90 Cryoablation Needle
- Z-0671-2021 · CompletedIceSphere" 1.5 Cryoablation Needle
- Z-0672-2021 · CompletedIceSphere" 1.5 S 90 Cryoablation Needle
- Z-0673-2021 · CompletedIceSphere" 1.5 90 Cryoablation Needle
- Z-0674-2021 · CompletedIceSphere" 1.5 Cryoablation Needle
- Z-0675-2021 · CompletedIceSeed" 1.5 90 Cryoablation Needle
- Z-0676-2021 · CompletedIceSeed" 1.5 Cryoablation Needle
- Z-0677-2021 · CompletedIceEDGE" 2.4 90p Cryoablation Needle
- Z-0678-2021 · CompletedIceRod" 1.5 MRI 90 Cryoablation Needle
- Z-0679-2021 · CompletedIceRod" 1.5 MRI Cryoablation Needle
- Z-0680-2021 · CompletedIceSeed" 1.5 MRI 90 Cryoablation Needle
- Z-0681-2021 · CompletedIceSeed" 1.5 MRI Cryoablation Needle
- Z-0682-2021 · CompletedIceFORCE" 2.1 CX Prostate Cryoablation Kit
- Z-0683-2021 · CompletedIcePearl" 2.1 CX Prostate Cryoablation Kit
- Z-0684-2021 · CompletedThree IceFORCE" 2.1 CX Prostate Cryoablation Kit
- Z-0685-2021 · CompletedThree IcePearl" 2.1 CX Prostate Cryoablation Kit
- Z-0686-2021 · CompletedIceRod" i-Thaw" Prostate Cryoablation Kit
- Z-0687-2021 · CompletedIceSeed" Prostate Cryoablation Kit
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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