Reported Jun 29, 2022 · Completed

CardioTek EP-TRACER Software V2.x.

CardioTek BV

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: CardioTek BV · Amerikalaan 70 · Maastricht-Airport · N/A

Is this the product you have?

  • CardioTek EP-TRACER Software V2.x.
Lot codes and dates
  • EP-TRACER 38 UDI/DI04260441455418
  • Serial Numbers

    117 of 117 codes

    • 2019-1-01
    • 2019-1-02
    • 2019-1-03
    • 2019-1-04
    • 2019-1-05
    • 2019-1-06
    • 2019-2-01
    • 2019-2-02
    • 2019-2-03
    • 2019-2-04
    • 2019-2-05
    • 2019-3-01
    • 2019-3-02
    • 2019-3-03
    • 2019-3-04
    • 2019-3-05
    • 2019-3-06
    • 2019-3-07
    • 2019-3-08
    • 2019-3-09
    • 2019-3-10
    • 2019-4-01
    • 2019-4-02
    • 2019-4-03
    • 2019-4-04
    • 2019-4-05
    • 2019-4-06
    • 2019-4-07
    • 2019-4-08
    • 2019-4-09
    • 2019-4-10
    • 2019-5-01
    • 2019-5-02
    • 2019-5-03
    • 2019-5-04
    • 2019-5-05
    • 2020-1-01
    • 2020-1-02
    • 2020-1-03
    • 2020-1-04
    • 2020-1-05
    • 2020-1-06
    • 2020-1-07
    • 2020-1-08
    • 2020-1-09
    • 2020-1-10
    • 2020-1-11
    • 2020-1-12
    • 2020-1-13
    • 2020-1-14
    • 2020-1-15
    • 2020-2-01
    • 2020-2-02
    • 2020-2-03
    • 2020-2-04
    • 2020-2-05
    • 2020-2-06
    • 2020-2-07
    • 2020-2-08
    • 2020-2-09
  • EP-TRACER 102 UDI/DI04260441455234
  • Serial Numbers
    • 2019-1-11
    • 2019-2-11
    • 2019-2-12
    • 2019-2-13
    • 2019-2-14
    • 2019-2-15
    • 2019-2-16
    • 2019-4-21
    • 2019-4-22
    • 2019-4-23
    • 2019-4-24
    • 2019-4-25
    • 2019-4-26
    • 2019-4-27
    • 2020-1-26
    • 2020-1-27
    • 2020-1-28
    • 2020-1-29
    • 2020-1-30
    • 2020-2-26
    • 2020-2-27
    • 2020-2-28
    • 2020-2-29
    • 2020-2-30
    • 2021-1-13
    • 2021-1-14
    • 2021-2-27
    • 2022-1-26
    • 2022-1-27
Amount recalled
146 units

Where it was sold

Why it was recalled

Device did not pass electrical safety testing for adequate insulation.

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

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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, 6:18 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.