Reported Dec 30, 2020 · Completed

IceRod" He-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" He-Thaw Prostate Cryoablation Kit
Lot codes and dates
  • UPNFPRPR4570
  • UDIs
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830105
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
    • 7290104830099
  • Batch Numbers
    • G5063
    • G5871
    • G5900
    • G5902
    • G5975
    • P1901
    • P2150
    • P2204
    • P2206
    • P2207
    • P2240
    • P2241
    • P2242
    • P2243
    • P2245
    • P2247
    • P2249
    • P2251
    • P2253
    • P2254
    • P2256
    • P2258
    • P2259
    • P2261
    • P2262
    • P2263
    • P2268
    • P2272
    • P2274
    • P2404
    • P2405
    • P2406
    • P2411
Amount recalled
115 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, 5:38 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.