CareFusion 203, Inc.: CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).

Recall number

Z-0074-2012

Recalling firm

CareFusion 203, Inc.

Product

CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. EnVe is a portable critical care ventilator. It is suitable for a wide range of life support and critical care applications. The ventilator normally operates from external DC power. When the ventilator is portable, a Removable Battery Pack powers the unit. Devices are designed for use on patients who require respiratory support or mechanical ventilation and weigh a minimum of 5 kg (11 lbs).

Status

Terminated

Initiated

2011-09-12

Posted

2011-10-26

Terminated

2012-11-22

Reason

CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions.

Root cause

Device Design

Action

The firm, CareFusion, sent an "URGENT PRODUCT RECALL" letter dated September 12, 2011 to its customers.The letter identified affected product, described the 3 issues providing the description of the event, potential risk, and provided required action for Users. The letter also stated that CareFusion would be contacting the facility to coordinate the corrective action. If you have any questions and/or need support, please contact CareFusion Technical Support at 1-800-554-8933 from Mon. - Fri. 8:00am -5:00pm Pacific Time.

Quantity

128 units

Distribution

Nationwide distribution: USA including states of: CA, CO, FL, IL, MI, MN, MT, ND, NJ, NM, NY, OK, PA, TX, UT, WI, and WV.

Lot, serial or model codes

serial numbers: 45317, 45318, 45319, 45321, 45323, 45324, 45326, 45327, 45328, 45330, 45331, 45332, 45333, 45334, 45336, 45338, 45339, 45341, 45735, 45736, 45737, 45738, 45740, 45741, 45742, 45744, 45745, 45746, 45747, 45748, 45749, 45750, 45751, 45752, 45754, 45902, 45905, 45906, 45907, 45908, 45909, 45910, 46038, 46039, 46040, 46041, 46042, 46043, 46044, 46046, 46050, 46051, 46632, 46634, 46635, 46636, 46637, 46638, 46640, 46641, 46642, 46643, 46644, 46645, 47069, 47070, 47071, 47073, 47074, 47075, 47076, 47077, 47078, 47079, 47081, 47082, 47083, 47210, 47211, 47213, 47214, 47215, 47216, 47217, 47219, 47221, 47222, 47223, 47224, 47225, 47226, 47229, 47230, 47231, 47233, 47234, 47236, 47237, 47238, 47239, 47538, 47539, 47540, 47541, 47542, 47544, 47545, 47546, 47547, 47548, 47549, 47550, 47551, 47552, 47553, 47554, 47555, 47556, 47557, 47558, 47559, 47560, 47561, 47562, 47563, 47564, 47566, 47567.

510(k) numbers

["K070594"]

PMA numbers

not on file

Product code

CBK

Firm FEI

3002617992

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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