PASCAL Precision Transcatheter Valve Repair System — Class II medical device recall Z-2479-2023
Ongoing recall by Edwards Lifesciences, LLC, reported 2023-09-06. Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or t
| Recall number | Z-2479-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2023-07-27 |
| Classified | 2023-08-29 |
| Reported by FDA | 2023-09-06 |
| Countries outside the US | AT, BE, CH, CY, DE, GB, GR, IE, IL, IT, LU, PL |
| Quantity | 92 |
| Serial numbers | 10700424, 10700439, 10776944, 10776966, 10776982, 10809836, 10809844, 10809849, 10809852, 10844243, 10844251, 10844264, 10844281, 10844284, 10844288, 10844292, 10844300, 10844302, 10844305, 10844551, 10844558, 10844563, 10844564, 10844566, 10844571 and 194 more |
| Model numbers | 20000IS, 20000ISM |
Product
PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
Reason for recall
Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rotation or additional implant implantation.
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-2479-2023. 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.