Rhythm Xience Guider Catheter Introducer with Lancer Intergrated… — Class II medical device recall Z-1768-2020
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-1768-2020 |
|---|---|
| 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 | 108 units |
| Reason classes | foreign material, specification failure |
| Lot numbers | 19040503, 19052007, 19061317 |
| Model numbers | 112852 |
Product
Rhythm Xience Guider Catheter Introducer with Lancer Intergrated Dilator/Transseptal Needle, Ref 112852, Sterile EO, 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-1768-2020. 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.