# FDA recall Z-1193-2019

> **Edwards Lifesciences, LLC** · Class I · device recall initiated 2019-03-21.

## Product

EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS    Product Usage:  EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume View sensor).

## Reason for recall

Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

## Distribution

Worldwide Distribution - US Nationwide :  FL, MD, NY, TX, VA, CO, OK, MO, CA, DE, TN, NC, DC, PA, MA, OR, SC, OH, WI, KS, NV, MI, IL, KY, GA, NJ, WA, CT, IN, MN, WV, LA, MS, AL, SD, NE, IA, AZ, ID, HI, UT, ME,MT, NM, AK, NH, RI, AR, ND, WY, PR.     Foreign (OUS):  IT, FI, CO, KR, JP, PL, BE, GR, NL, IL, AT, DK,CA, GB, BR, SA, SE, DE, AU, FR, MX, IN, IC, ZA, ES, TR, NZ, MY, IE, SG, CZ, SI, PT, CH, RE, LK, CR, AR, HK, NO, PY, PA, MT, EG, NP, TN, RU, RO, NA,CL, BH, IR, PH, TH, KZ, DZ, BG, EE, KW, VN, OM, PE, EC, AE, MA, VE, BO, QA, DO, GT, BY, JO, LT, SK, HU, CY, MN, TW, CN

## Key facts

- **Recall number:** Z-1193-2019
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-21
- **Report date:** 2019-05-29
- **Termination date:** 2023-11-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Irvine, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1193-2019

## Citation

> AI Analytics. FDA recall Z-1193-2019. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1193-2019. Source: US FDA. Licensed CC0.

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