Reported Dec 30, 2020 · Completed

IceSeed" 1.5 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?

  • IceSeed" 1.5 90¿ Cryoablation Needle
Lot codes and dates
  • UPNFPRPR3202
  • UDIs
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
    • 7290104830235
  • Batch Numbers
    • U1165
    • U1166
    • U0911
    • U0912
    • U0397
    • U0381
    • U0368
    • T0791
    • T0790
    • T0465
    • T0464
    • T0050
    • T0051
    • A6981
    • A6980
    • A2129
    • A2128
    • A1635
    • A1636
    • A1528
    • A1392
    • A1391
    • A0944
    • A0943
    • A0408
    • A0407
    • A0284
Amount recalled
788 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.

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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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.