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
- UPNFPRPR3260
- UDIs
072901048302590729010483025907290104830259072901048302590729010483025907290104830259
- Batch Numbers
U0326U0325U0286U0285A7012A7011
- Amount recalled
- 92 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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