IceFORCE" 2.1 CX L 90 Cryoablation Needle recallZ-0659-2021 · 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-0659-2021
- Status
- Completed
- Initiated by the company
- Nov 18, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 740 units
- Product code
- GEI
- FDA submissions
- K162599
- Distribution
- Nationwide
Product description
IceFORCE" 2.1 CX L 90 Cryoablation Needle
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
UPN: FPRPR3618 UDIs: 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089, 7290104831089 Batch Numbers: U1214, U1215, U1112, U1113, U0958, U0959, U0861, U0862, U0765, U0766, U0729, U0730, U0645, U0643, U0644, U0642, U0426, U0425, U0408, U0160, U0161, T0278, T0275, T0143, T0142, T0134, T0135, A7082, A7032, A7033, A6677, A6678, A2030, A2029, A1775, A1774, A1658, A1544, A1545, A1526, A1188, A1189
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- IceFORCE™ 2.1 CX L 90° Cryoablation Needle FPRPR3618Boston Scientific Corporation · Unit, Cryosurgical, Accessories2 recalls6 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-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-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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