Reported Dec 30, 2020 · Completed
IceSeed" 1.5¿ MRI 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¿ MRI 90¿ Cryoablation Needle ¿
- Lot codes and dates
- UPNFPRPR3194
- UDIs
729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280729010483028072901048302807290104830280
- Batch Numbers
U1368U1367U1040U0396U0380U0375U0374U0242U0241T0532T0533T0531T0530T0444T0443T0442T0353T0354T0262T0263A6720A6719A6698A6697A2049A2050A1999A1998A1990A1991A1891A1890A1844A1845A1690A1562A1563A1533A1326A1325A1197A1196A1041A1040A1008A1007A0955A0954
- Amount recalled
- 1,526 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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