Reported Dec 30, 2020 · Completed
Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
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?
- Three IceFORCE" 2.1 CX Prostate Cryoablation Kit
- Lot codes and dates
- UPNFPRPR3607
- UDIs
72901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058729010483105872901048310587290104831058
- Batch Numbers
U1302U1303U1301U1032U0616U0590U0589U0583U0540U0363U0318U0083T0552T0163T0154A6915A6849A6848A6757A6754A1782A1569A1567A1436A1298A1194
- Amount recalled
- 140 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.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.