Reported Dec 30, 2020 · Completed

IceRod" 1.5 MRI 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 MRI 90¿ Cryoablation Needle¿
Lot codes and dates
  • UPNFPRPR3195
  • UDIs

    114 of 114 codes

    • 7290104830297
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    • 7290104830297
  • Batch Numbers

    114 of 114 codes

    • U1406
    • U1407
    • U1370
    • U1369
    • U1041
    • U1042
    • U0611
    • U0610
    • U0501
    • U0419
    • U0447
    • U0444
    • U0418
    • U0322
    • U0323
    • U0211
    • U0243
    • U0244
    • U0208
    • U0209
    • U0210
    • U0189
    • U0188
    • U0175
    • U0174
    • U0031
    • U0164
    • U0005
    • U0004
    • U0002
    • U0001
    • T0786
    • T0785
    • T0664
    • T0665
    • T0649
    • T0650
    • T0562
    • T0561
    • T0452
    • T0451
    • T0445
    • T0441
    • T0440
    • T0364
    • T0365
    • T0361
    • T0360
    • T0192
    • T0193
    • T0179
    • T0180
    • A7213
    • A6715
    • A6714
    • A6712
    • A6711
    • A6672
    • A6673
    • A2093
Amount recalled
3,894 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, 4:52 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.