IceRod" 1.5 PLUS 90 Cryoablation Needle recallZ-0666-2021 · 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-0666-2021
- Status
- Completed
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 4,645 units
- Product code
- GEH
- FDA submissions
- K110946
- Distribution
- Nationwide
Product description
IceRod" 1.5 PLUS 90 Cryoablation Needle
Code information (models, lots, serial numbers)
Show the full code information (3k characters)
UPN: FPRPR3508 UDIs: 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563, 7290104830563 Batch Numbers: U1442, U1443, U1435, U1434, U1371, U1372, U1360, U1361, U1020, U1038, U1019, U1017, U1018, U0436, U0392, U0373, U0372, U0327, U0333, U0336, U0334, U0335, U0332, U0329, U0330, U0294, U0289, U0291, U0292, U0290, U0293, U0212, U0213, U0061, U0063, U0044, U0043, U0006, U0007, T0499, T0498, T0342, T0340, T0341, T0328, T0314, T0300, T0298, T0299, T0115, T0116, T0111, T0112, T0068, T0069, T0052, T0053, T0034, T0035, A7228, A7227, A7185, A7184, A7169, A7170, A7171, A7168, A7132, A7133, A7123, A7028, A7029, A7000, A7001, A6971, A6970, A6950, A6951, A6792, A6793, A6778, A6777, A6771, A6772, A6736, A6735, A6699, A6700, A6692, A6693, A6685, A6686, A6665, A6666, A6662, A6661, A6653, A6654, A2115, A2114, A2098, A2097, A2048, A2022, A2009, A2007, A2008, A2006, A1997, A1985, A1984, A1898, A1897, A1830, A1831, A1821, A1822, A1816, A1817, A1808, A1807, A1663, A1664, A1655, A1656, A1593, A1480, A1481, A1456, A1457, A1450, A1451, A1410, A1411, A1367, A1239, A1240, A1237, A1238, A1212, A1213
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IceRod® 1.5 PLUS 90° Cryoablation Needle FPRPR3508Boston Scientific Corporation · Unit, Cryosurgical, Accessories1 recall28 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-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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