Medical Devices

CareFusion 203, Inc., EnVe and ReVel ventilators - Power Connection Failure

Recall Class: Class I

Date Recall Initiated: August 5, 2014

Products: CareFusion 203, EnVe and ReVel ventilators

  • Manufacturing Dates: May, 2009 - August 2014
  • Distribution Dates: December 10, 2010 - August 6, 2014.

Lot Numbers: See Affected Lot Numbers below. (Added October 17, 2014)

Use: The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).  They are used in hospitals, during transport of a patient and at home to provide constant or intermittent respiratory support.

Recalling Firm:
CareFusion 203, Incorporated
17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341

Reason for Recall:
CareFusion 203 recalled these devices because of the potential for damage to their power cord adaptors which can cause loss of power and complete shut off.

The EnVe and ReVel ventilators can be operated using either batteries or external power sources (AC or auto lighters). The firm recalled these devices because they found that the pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death.

The company has received 256 reports of the incident with no reported injuries or deaths.

Public Contact: For questions regarding the operation and/or servicing of affected CareFusion ventilators in the United States, call the CareFusion Recall Center at 888.562.6018, Monday through Friday, 7:00 a.m. – 4:00 p.m., Pacific Time or via email at SupportCenter@carefusion.com.

FDA District: Minneapolis District Office

More information about this Recall:

CareFusion sent customers a Product Recall Notice letter on August 8, 2014. The letter identified the product, problem and actions to be taken. The letter also said that two new power adaptor accessory kits for the ReVel and EnVe ventilators would be sent to correct the problem.

CareFusion recommends that the user:

  1. Plug in the new AC Power Adapters and return a confirmation for each one used.
  2. Identify the ventilator serial numbers and/or serial numbers of AC Power Adapters, and Auto Lighter Power Cords which have been attached.

About Class I Recalls:

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Affected Lot Numbers:

SERIAL # ENVE CUSTOMER UNITS: 26562 44554 44559 45317 45322 45324 45328 45330 45333 45334 45336 45339 45341 45343 45736 45737 45740 45741 45742 45744 45745 45750 45751 45752 45907 45908 46040 46041 46043 46044 46050 46051 46632 46636 46641 46642 46643 46644 46645 46646 47069 47071 47073 47075 47076 47077 47078 47079 47080 47081 47082 47210 47211 47213 47214 47215 47216 47217 47219 47221 47223 47225 47226 47227 47229 47230 47231 47232 47233 47234 47236 47237 47238 47239 47538 47539 47541 47542 47543 47544 47545 47546 47547 47548 47549 47550 47551 47552 47553 47554 47555 47556 47557 47558 47559 47560 47561 47562 47563 47564 47565 47566 47567 48759 48760 48761 48762 48763 48764 48765 48766 48767 48768 48769 48770 48771 48772 48773 48774 48775 48776 48777 48778 48779 48780 48781 48782 48783 48784 48785 48786 48787 48788 48868 48869 48870 48871 48872 48873 48874 48875 48876 48877 48878 48879 48881 48883 48884 48885 48886 48887 48888 48889 48890 48891 48892 48893 48894 48895 48896 48897 50390 50391 50392 50393 50394 50395 50397 50398 50401 50405 50409 50411 50412 50415 50416 50417 50418 50419 50648 50650 50651 50652 50654 50656 50657 50658 50659 50660 50662 50663 50664 50665 50666 50667 50668 50669 50671 50672 50673 50674 51569 51570 51572 51573 51574 51575 51576 51578 51579 51580 51582 51583 51584 51585 51586 51587 51588 51589 51590 51591 51592 51593 51594 51595 51596 51597 51598 52222 52223 52224 52225 52226 52227 52228 52229 52230 52231 52372 52373 52376 52377 52378 52380 52381 52594 52595 52596 52597 52598 52599 52600 52601 52602 52603 52604 52605 52606 52608 61822 61823 61825 64594 64595 64596 64597 64598 64599 64600 64601 65295 65296 65297 65298 65299 65301 65302 65303 65454 65455 65456 65457 65458 65459 65460 65461 65462 65463 65464 65465 65466 65467 65468 65469 65470 65471 65472 65473 66398 66399 66400 66401 66402 66403 66404 66405 66406 66407 66408 66409 67353 67354 67355 67356 67357 67358 67359 67360 67361 67362 67363 67364 67365 67366 67367 67368 67369 67370 68903 68904 68905 68906 68907 68908 68909 68910 69803 69804 69805 69806 69807 69808 69809 69810 69811 69812 70037 70043 70044 70248 70249 70250 70251 70252 70253 70254 70255 70256 70257 70755 70756 70757 70758 70759 70760 70761 70762 70763 70764 71045 71046 71047 71048 71049 71050

REVEL CUSTOMER UNITS: SERIAL # 48381 48384 48386 48387 48389 48390 48391 48396 48397 48399 48400 48401 48404 48405 48406 48407 48408 48409 48410 50360 50361 50362 50363 50364 50365 50366 50367 50368 50369 50370 50371 50373 50374 50375 50376 50378 50379 50382 50386 50387 50388 50389 50618 50619 50623 50624 50625 50626 50627 50628 50629 50630 50631 50632 50633 50634 50635 50638 50639 50641 50642 50645 50647 51599 51600 51601 51602 51603 51604 51605 51606 51607 51608 51609 51610 51611 51612 51613 51614 51615 51616 51618 51619 51620 51621 51622 51623 51624 51625 51626 51628 51994 51995 51998 51999 52000 52001 52002 52003 52004 52005 52006 52007 52008 52009 52010 52013 52014 52017 52018 52019 52020 52021 52022 52558 52560 52561 52562 52563 52564 52565 52566 52567 52568 52569 52570 52571 52572 52573 52574 52576 52577 53229 53230 53231 53232 53233 53234 53235 53236 53237 53238 55683 55684 55685 55686 55687 55688 55689 55690 55691 55692 55693 55694 55695 55696 55697 55698 55699 55700 55701 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Page Last Updated: 10/17/2014
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