Edwards TruWave x 2 — Class II medical device recall Z-1961-2021
Terminated recall by Edwards Lifesciences, LLC, reported 2021-07-07, distributed in AZ, CA, CO, CT, DC, DE, FL, GA…. There is a potential that the pressure tubing may detach from the blood sampling system
| Recall number | Z-1961-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2021-05-26 |
| Classified | 2021-06-25 |
| Reported by FDA | 2021-07-07 |
| Terminated | 2023-12-14 |
| Distributed | AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, PR, SD, TX, UT, VA, WA, WI, WV |
| Countries outside the US | CA, GB, IT |
| Quantity | 290 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 57460691930174 |
| Lot numbers | 63479666 |
| Model numbers | T443952B |
Product
Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691930174 ***Not Marketed within the US
Reason for recall
There is a potential that the pressure tubing may detach from the blood sampling system
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-1961-2021. 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.