IceSphere" 1.5 90 Cryoablation Needle recallZ-0670-2021 · 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-0670-2021
- Status
- Completed
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 2,429 units
- Product code
- GEH
- FDA submissions
- K141485
- Distribution
- Nationwide
Product description
IceSphere" 1.5 90 Cryoablation Needle
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
UPN: FPRPR3560 UDIs: 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945, 7290104830945 Batch Numbers: U1454, U1455, U1456, U1420, U1421, U1325, U1326, U1328, U1327, U0435, U0432, U0369, U0351, U0352, T0403, T0402, T0395, T0394, T0305, T0146, T0126, T0006, T0023, T0024, T0018, T0015, A7205, A6966, A6967, A6969, A6968, A6943, A6942, A6917, A6918, A2089, A2090, A1858, A1857, A1848, A1847, A1823, A1824, A1819, A1818, A1811, A1812, A1801, A1802, A1794, A1793, A1785, A1786, A1601, A1602, A1591, A1592, A1489, A1490, A1477, A1478, A1309, A1308, A1294, A1295, A1293, A1292, A1265, A1264, A1250, A1251, A1242, A1241
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IceSphere® 1.5 90° Cryoablation Needle FPRPR3560Boston Scientific Corporation · Unit, Cryosurgical, Accessories1 recall14 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-0660-2021 · CompletedIcePearl" 2.1 CX 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-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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