Reported Dec 30, 2020 · Completed

IceSeed" 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?

  • IceSeed" Prostate Cryoablation Kit
Lot codes and dates
  • UPNFPRPR4518
  • UDIs
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
    • 7290104830075
  • Batch Numbers
    • U1262
    • U1114
    • U1036
    • U0910
    • U0909
    • U0863
    • U0365
    • U0280
    • U0281
    • U0180
    • U0088
    • U0038
    • T0529
    • T0457
    • T0235
    • T0178
    • T0058
    • A6911
    • A6835
    • A6695
    • A6648
    • A2133
    • A2040
    • A2033
    • A1889
    • A1634
    • A1368
    • A1225
Amount recalled
211 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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:36 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.