Reported Dec 30, 2020 · Completed
IceRod" 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?
- IceRod" 1.5 CX 90¿ Cryoablation Needle¿
- Lot codes and dates
- UPNFPRPR3533
- UDIs
561 of 561 codes
729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587729010483058772901048305877290104830587
- Batch Numbers
561 of 561 codes
U1450U1445U1437U1436U1419U1415U1413U1411U1412U1414U1417U1418U1416U1408U1410U1409U1405U1382U1377U1379U1381U1384U1385U1383U1373U1376U1375U1380U1378U1374U1366U1323U1321U1314U1317U1318U1320U1322U1324U1315U1316U1319U1313U1172U1168U1126U1169U1170U1171U1173U1167U1124U1120U1087U1085U1119U1122U1125U1086U1123
- Amount recalled
- 18,731 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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