Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX… — Class II medical device recall Z-1771-2020
Terminated recall by Acutus Medical Inc, reported 2020-04-29, distributed in AZ, CA, SC. It has been determined that the manufacturing process may have left foreign material particulates on the finis
| Recall number | Z-1771-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acutus Medical Inc, Carlsbad, CA, United States |
| Recall initiated | 2020-02-25 |
| Classified | 2020-04-23 |
| Reported by FDA | 2020-04-29 |
| Terminated | 2021-04-27 |
| Distributed | AZ, CA, SC |
| Quantity | 5 units |
| Reason classes | foreign material, specification failure |
| Lot numbers | 19101020 |
| Model numbers | 122852 |
Product
Acutus Medical AcQGuide Flex Steerable Introducer with AcQcross QX Integrated Dilator/Transseptal Needle, REF: 122852, SterileEO RxOnly
Reason for recall
It has been determined that the manufacturing process may have left foreign material particulates on the finished device. This could result in a range of event from procedure delay to pulmonary embolism.
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-1771-2020. 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.