Reported Dec 30, 2020 · Completed
IcePearl" 2.1 CX L 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?
- IcePearl" 2.1 CX L 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3617
- UDIs
72901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072729010483107272901048310727290104831072
- Batch numbers
U1310U1309U1306U1305X0828U0727U0728U0641U0640U0587U0586U0585U0084A7113A6977A6963A6962A6681A6682A1657A1522A1178A1177
- Amount recalled
- 261 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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