QuickDraw Venous Cannula — Class II medical device recall Z-0800-2020
Terminated recall by Edwards Lifesciences, LLC, reported 2020-01-22, distributed in AL, AR, AZ, CA, CO, CT, DE, FL…. If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal
| Recall number | Z-0800-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Irvine, CA, United States |
| Recall initiated | 2019-11-27 |
| Classified | 2020-01-10 |
| Reported by FDA | 2020-01-22 |
| Terminated | 2024-05-28 |
| Distributed | AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
| Countries outside the US | AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, ES, FR, GB, GR, IE, IL, IT, JO, JP, MY, PL, PT, RO, SA, SE, TH, ZA |
| Quantity | 27,168 |
| UPC / GTIN / UDI-DI | 00690103182699, 00690103182705 |
| Model numbers | QD22, QD25 |
Product
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
Reason for recall
If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss.
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-0800-2020. 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.