Reported Dec 30, 2020 · Completed
IceSphere" 1.5 S 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?
- IceSphere" 1.5 S 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3561
- UDIs
729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556729010483055672901048305567290104830556
- Batch Numbers
U1176U1175U0460U0459U0157T0702T0389T0390T0371T0370T0064T0065T0045T0044A7075A7074A6873A6872A1632A1633A1616A1615A1363A1364
- Amount recalled
- 729 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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