Reported Feb 14, 2018 · Ongoing

Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2

Covidien LLC

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: Covidien LLC · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Covidien Emprint Percutaneous Antenna with Thermosphere Technology, 20cm (reinforced), Material CA20L2
Lot codes and dates
  • UDI 10884521706590
  • Lot codes
    • S6MG006PX
    • S6MG009PX
    • S6MG013PX
    • S6MG020PX
    • S7AG011X
    • S7AG012X
    • S7BG008X
    • S7CG003X
    • S7DG003X
    • S7DG009X
    • S7FG001X
    • S7FG002X
    • S7FG005X
    • S7FG008X
Amount recalled
N/A

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

  • Nationwide
  • PR

Why it was recalled

The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

This product could cause temporary or reversible health problems — stop using it.

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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, 5:28 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.