Reported Dec 30, 2020 · Completed

IceRod" i-Thaw" 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?

  • IceRod" i-Thaw" Prostate Cryoablation Kit
Lot codes and dates
  • UPNFPRPR3572
  • UDIs

    111 of 111 codes

    • 7290104830983
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  • Batch Numbers

    111 of 111 codes

    • U1423
    • U1422
    • U1329
    • U1227
    • U1091
    • U1128
    • U1127
    • U1090
    • U0976
    • U1011
    • U0919
    • U0917
    • U0868
    • U0869
    • U0738
    • U0739
    • U0403
    • U0404
    • U0297
    • U0296
    • U0256
    • U0255
    • U0217
    • U0218
    • U0034
    • U0176
    • U0033
    • U0032
    • U0016
    • U0040
    • U0015
    • T0759
    • T0758
    • T0731
    • T0651
    • T0634
    • T0524
    • T0507
    • T0502
    • T0470
    • T0429
    • T0401
    • T0391
    • T0372
    • T0351
    • T0319
    • T0306
    • T0281
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    • T0247
    • T0198
    • T0189
    • T0161
    • T0084
    • T0074
    • T0008
    • A7231
    • A7212
    • A7206
    • A7188
Amount recalled
947 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, 6:17 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.