CardioTek EP-TRACER Software V2 — Class II medical device recall Z-1283-2022
Completed recall by CardioTek BV, reported 2022-06-29, distributed nationwide. Device did not pass electrical safety testing for adequate insulation.
| Recall number | Z-1283-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | CardioTek BV, Maastricht-Airport, Netherlands |
| Recall initiated | 2022-04-25 |
| Classified | 2022-06-23 |
| Reported by FDA | 2022-06-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BR, CA, CL, CO, DE, EC, ES, FI, GB, HR, HU, IL, IT, KR, MX, MY, NL, PL, PT, SA, SE, SI, TR |
| Quantity | 146 units |
| UPC / GTIN / UDI-DI | 04260441455234, 04260441455418 |
| Serial numbers | 102, 2020-2-30 |
Product
CardioTek EP-TRACER Software V2.x.
Reason for recall
Device did not pass electrical safety testing for adequate insulation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1283-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.