Reported Dec 30, 2020 · Completed

IceFORCE" 2.1 CX 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?

  • IceFORCE" 2.1 CX 90¿ Cryoablation Needle
Lot codes and dates
  • UPNFPRPR3602
  • UDIs

    1,049 of 1,049 codes

    • 7290104831003
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    • 7290104831003
  • Batch Numbers

    1,049 of 1,049 codes

    • U1397
    • U1395
    • U1359
    • U1357
    • U1396
    • U1394
    • U1355
    • U1353
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    • U1350
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    • U1339
    • U1298
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    • U1286
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    • U1277
    • U1297
    • U1281
    • U1275
    • U1289
    • U1295
    • U1260
    • U1258
    • U1256
    • U1254
    • U1252
    • U1204
    • U1246
    • U1247
Amount recalled
22,289 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.