CLASS I Device recall · Reported 29 May 2019 · FDA Enforcement Report
EV1000 Clinical Platform recalled by Edwards Lifesciences
Edwards Lifesciences is recalling EV1000 Clinical Platform, distributed nationwide in the US. The recall was initiated on 21 Mar 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1193-2019
- FDA event ID
- 82456
- Recalling firm
- Edwards Lifesciences, Irvine, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 21 Mar 2019
- FDA classified
- 21 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 21 Mar 2019 | Recall initiated by company | |
| 21 May 2019 | Classified by FDA | +61 days |
| 29 May 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
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
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is EV1000 Clinical Platform recalled?
Yes. Edwards Lifesciences recalled EV1000 Clinical Platform on 21 Mar 2019. The recall is Class I and its status is Terminated. Recall number Z-1193-2019.
Why was it recalled?
Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.
Which lots are affected?
All lots
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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