Reported Dec 30, 2020 · Completed
IceSphere" 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?
- IceSphere" 1.5 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3560
- UDIs
73 of 73 codes
729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945729010483094572901048309457290104830945
- Batch Numbers
73 of 73 codes
U1454U1455U1456U1420U1421U1325U1326U1328U1327U0435U0432U0369U0351U0352T0403T0402T0395T0394T0305T0146T0126T0006T0023T0024T0018T0015A7205A6966A6967A6969A6968A6943A6942A6917A6918A2089A2090A1858A1857A1848A1847A1823A1824A1819A1818A1811A1812A1801A1802A1794A1793A1785A1786A1601A1602A1591A1592A1489A1490A1477
- Amount recalled
- 2,429 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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