Reported Dec 30, 2020 · Completed
IceRod" 1.5 PLUS 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 PLUS 90¿ Cryoablation Needle
- Lot codes and dates
- UPNFPRPR3508
- UDIs
141 of 141 codes
729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563729010483056372901048305637290104830563
- Batch Numbers
141 of 141 codes
U1442U1443U1435U1434U1371U1372U1360U1361U1020U1038U1019U1017U1018U0436U0392U0373U0372U0327U0333U0336U0334U0335U0332U0329U0330U0294U0289U0291U0292U0290U0293U0212U0213U0061U0063U0044U0043U0006U0007T0499T0498T0342T0340T0341T0328T0314T0300T0298T0299T0115T0116T0111T0112T0068T0069T0052T0053T0034T0035A7228
- Amount recalled
- 4,645 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.