CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands CardioTek EP-TRACER Software V2.x. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CardioTek EP-TRACER Software V2.x.
Brand
CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands
Lot Codes / Batch Numbers
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
Products Sold
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
CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands is recalling CardioTek EP-TRACER Software V2.x. due to Device did not pass electrical safety testing for adequate insulation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device did not pass electrical safety testing for adequate insulation.
Recommended Action
Per FDA guidance
The firm issued a recall notification to consignees on 04/25/2022 via email. On 05/24/2022 the firm sent an updated field safety notice. The consignee can continue to use the device. The firm will contact the customer to schedule an appointment for the rework. The consignee is to pass on the letter to those that need to be made aware of the notice.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026