Reported Dec 30, 2020 · Completed
IceSeed" 1.5 90¿ Cryoablation Needle
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?
- IceSeed" 1.5 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3202
- UDIs
729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235729010483023572901048302357290104830235
- Batch Numbers
U1165U1166U0911U0912U0397U0381U0368T0791T0790T0465T0464T0050T0051A6981A6980A2129A2128A1635A1636A1528A1392A1391A0944A0943A0408A0407A0284
- Amount recalled
- 788 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.
Want the full recall guide?
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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