Reported Dec 30, 2020 · Completed
Five IceSphere" Prostate Cryoablation Kit
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
- Five IceSphere" Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR3570
- UDIs
72901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969729010483096972901048309697290104830969
- Batch Numbers
U1402U1223U1224U1225U1177U1178U1118U1115U1070U1069U0824U0825U0823U0826U0470U0411U0402U0407U0384U0389U0216U0183U0122U0154U0155T0673T0672T0635T0484T0483T0461T0462T0373T0374T0363T0362T0127T0104T0103A7009A6953A6952A6890A6789A6737A2101A2088A1629A1626A1607A1577A1382A1184
- Amount recalled
- 419 units
This recall covers 37 products
The agency filed one notice per product. You are reading one of them; the other 36 are below.
24 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Complaint trend regarding needle shaft gas leaks.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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