Reported Dec 30, 2020 · Completed
IceSeed" 1.5 MRI 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 Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3192
- UDIs
729010483026672901048302667290104830266729010483026672901048302667290104830266729010483026672901048302667290104830266729010483026672901048302667290104830266729010483026672901048302667290104830266729010483026672901048302667290104830266729010483026672901048302667290104830266
- Batch Numbers
U1438U1439U0962U0961U0437U0378T0697T0688T0388T0387A7150A7149A2018A2017A1711A1710A1689A1403A1404A0896A0897
- Amount recalled
- 627 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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