Continuous, Ventilator, Home Use

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-05-01Open, ClassifiedProcess change control

  VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

  Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk

• 2024-09-05Open, ClassifiedDevice Design

  Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benelux EV300; BR2200X18B Trilogy Evo, O2, Brazil EV300; CA2200X12B Trilogy Evo, O2, Canada EV300; DE2200X13B Trilogy Evo, O2, Germany EV300; DS2200X11B Trilogy Evo, O2, USA EV300; DS2200X11B Trilogy Evo, O2, USA EV300; EE2200X15B Trilogy Evo, O2, Eastern Europe EV300; ES2200X15B Trilogy Evo, O2, Spain EV300; EU2200X15B Trilogy Evo, O2, EU EV300; FR2200X14B Trilogy Evo, O2, France EV300; FX2200X15B Trilogy Evo, O2, INT EV300; GB2200X15B Trilogy Evo, O2, Great Britain EV300; IN2200X15B Trilogy Evo, O2, INTL EV300; IT2200X21B Trilogy Evo, O2, Italy EV300; KR2200X15B Trilogy Evo, O2, Korea EV300; ND2200X15B Trilogy Evo, O2, Nordics EV300; TR2200X15B Trilogy Evo, O2, Turkey EV300;

  Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

• 2024-09-05Open, ClassifiedDevice Design

  Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux BR2110X18B Trilogy Evo, Brazil CA2110X12B Trilogy Evo, Canada DE2100X13B Trilogy Evo O2, Germany DE2110X13B Trilogy Evo, Germany DS2100X11B Trilogy Evo, O2, USA DS2110X11B Trilogy Evo, USA DS2110X11B Trilogy Evo, USA EE2100X15B Trilogy Evo O2, Eastern Europe EE2110X15B Trilogy Evo, Eastern Europe ES2100X15B Trilogy Evo O2, Iberia ES2110X15B Trilogy Evo, Iberia EU2100X15B Trilogy Evo, O2, EU EU2100X19 Trilogy Evo, O2, EU (Non-BT) EU2110X15B Trilogy Evo, EU EU2110X19 Trilogy Evo, EU (Non-BT) FR2100X14B Trilogy Evo O2, France FR2110X14B Trilogy Evo, France FX2100X15B Trilogy Evo, O2, INT GB2110X15B Trilogy Evo, Great Britain IA2100X15B Trilogy Evo O2, India IA2110X15B Trilogy Evo, India IN2100X15B Trilogy Evo, O2, International IN2100X19 Trilogy Evo, O2, International (Non-BT) IN2110X15B Trilogy Evo, International IT2100X21B Trilogy Evo O2, Italy IT2110X21B Trilogy Evo, Italy JP2100X16B Trilogy Evo, O2, Japan JP2110X16B Trilogy Evo, Japan KR2110X15B Trilogy Evo, Korea LA2100X15B Trilogy Evo, O2, Latin America LA2110X15B Trilogy Evo, Latin America LD2110X23B Garbin Evo, Linde ND2100X15B Trilogy Evo O2, Nordics ND2110X15B Trilogy Evo, Nordics RDS2110X11B Trilogy Evo, USA-Rental SP2100X26B LifeVentEVO2 TR2110X15B Trilogy Evo, Turkey UDS2110X11B Trilogy Evo, USA-RECERT VT2110X24B Aeris EVO

  Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for affected ventilators. These updates resolve safety issues identified in earlier recalls.

• 2024-09-03Open, ClassifiedUnder Investigation by firm

  Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermittent ventilatory support for patients who require invasive or non-invasive mechanical ventilation, Model/Catalog Number: 230000 (230016, 230216)

  There is a potential for short term (<7 days) elevated levels of formaldehyde emitted from the device into the patient breathing airpath in specific conditions.

• 2023-11-27Open, ClassifiedProcess control

  with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.

  Produced with unintended open slits on the side of the mouthpiece body, may result in insufficient ventilation in spontaneous breathing patients using MPV-VCV and MPV-PCV modes of ventilation

• 2015-07-16TerminatedDevice Design

  Breas Vivo 50 Home Care Ventilator Product Usage: Respiratory Care

  Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop functioning as the device enters stand-by mode.

• 2004-12-08TerminatedOther

  Universal Cable Adaptor (Part #17765-001 and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV series Ventilator, Model 800 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall (FDA Z-1485-04).

  Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

• 2004-12-08TerminatedOther

  Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 950 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)

  Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

• 2004-12-08TerminatedOther

  Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 900 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)

  Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.

• 2004-12-08TerminatedOther

  Universal Cable Adaptor (Part #17765-001and labeled on outer package as part no. 17820-001) distributed for Field Installation on certain LTV Series Ventilator, Model 1000 with either part # 10134 or 11511 power boards affected by the Pulmonetic Systems, Inc., November 1, 2004 Class I recall. (FDA Z-1485-04)

  Reports have been received indicating that the Universal Cable Adaptor, intended to correct an earlier Class I recall of LTV Series Ventilators due to their inability to continue operating when external power source is switched to internal battery, is not functioning as intended and/or the cable is not securely attaching to the connection on the ventilator.