Reported Dec 30, 2020 · Completed
IceSphere" 1.5 CX 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 CX 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3573
- UDIs
205 of 205 codes
729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133729010483113372901048311337290104831133
- Batch Numbers
205 of 205 codes
U1458U1457U1459U1460U1461U1429U1428U1426U1427U1425U1430U1333U1331U1232U1230U1334U1332U1335U1330U1229U1231U1222U1221U1219U1220U1184U1182U1180U1179U1183U1181U1162U1161U1160U0982U0981U0977U0980U0922U0923U0920U0921U0872U0870U0871U0873U0519U0518U0508U0303U0300U0301U0302U0472U0299U0298U0262U0260U0259U0257
- Amount recalled
- 6,363 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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