CardioTek BV: Medical Device Recall in 2022 - (Recall #: Z-1283-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

CardioTek EP-TRACER Software V2.x.

Product Classification:

Class II

Date Initiated: April 25, 2022

Date Posted: June 29, 2022

Recall Number: Z-1283-2022

Event ID: 90154

Reason for Recall:

Device did not pass electrical safety testing for adequate insulation.

Status: Completed

Product Quantity: 146 units

Code Information:

EP-TRACER 38 UDI/DI: 04260441455418; Serial Numbers: 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, 2020-2-10, 2020-2-11, 2020-2-13, 2020-2-14, 2020-2-15, 2020-4-01, 2020-4-02, 2020-4-03, 2020-4-04, 2021-1-01, 2021-1-02, 2021-1-03, 2021-1-04, 2021-1-05, 2021-1-06, 2021-1-07, 2021-1-08, 2021-2-01, 2021-2-02, 2021-2-03, 2021-2-04, 2021-2-06, 2021-2-07, 2021-2-08, 2021-2-09, 2021-2-10, 2021-2-11, 2021-2-12, 2021-2-13, 2021-2-14, 2021-2-15, 2021-3-01, 2021-3-02, 2021-3-03, 2021-3-04, 2021-3-05, 2021-3-06, 2021-3-07, 2021-3-08, 2021-3-09, 2021-3-10, 2021-3-11, 2021-3-12, 2021-3-13, 2021-3-14, 2021-3-15, 2021-5-01, 2021-5-02, 2021-5-03, 2021-5-04, 2021-5-05, 2021-5-06, 2022-1-01, 2022-1-03, 2022-1-04, 2022-1-05, 2022-1-06; EP-TRACER 102 UDI/DI: 04260441455234; 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

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of CA, NY, NC and the countries of South Korea, Mexico, Kazakhstan, Netherlands, Spain, Germany, Finland, Poland, Israel, Turkey, Chile, Ecuador, Austria, Croatia, Sweden, United Kingdom, Colombia, Italy, Portugal, Canada, Saudi Arabia, Belgium, Slovenia, Brazil, Hungary, Malaysia, Uzbekistan.

Voluntary or Mandated:

Voluntary: Firm initiated