AVEA Ventilator (Catalog Code 17310, 17311, 17312) recallZ-0510-2012 · Carefusion 211 Inc · initiated Sep 8, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Carefusion 211 Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.
FDA root cause category: Nonconforming Material/Component
What the company is doing
CareFusion sent an "URGENT PRODUCT RECALL" letter dated September 25, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers were instructed to contact the firm by telephone to coordinate implementation of the corrective action at their site. Customers were instructed to return an enclosed response card to expedite the correction process and acknowledge receipt of the recall notification. Carefusion does not require that the customers return their devices. Customers will be contacted by a member of the CareFusion Technical Support Department to arrange for onsite remediation of the affected devices. In the interim, if any affected AVEA ventilator units in their facility exhibits a sustained Extended High Ppeak alarm followed by the opening of the Safety Valve, customers were instructed to remove the ventilator from service, provide alternate ventilation and contact Carefusion Technical Support (800) 213-2466 to report the issue. All ventilator dependent patients should be constantly monitored by qualified personnel to ensure that if a malfunction were to occur, alternate ventilation can be provided.
Recall details
- Recall number
- Z-0510-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 8, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Carefusion 211 Inc
- Quantity
- 6797 total, 1891 in US, 4906 worldwide
- Product code
- CBK
- FDA submissions
- K013642, K073069, K103211
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Cyprus, Estonia, Brazil, Kuwait, United Arab Emirates, Slovenia, Lithuania, Latvia, Belgium, Bermuda, Ecuador, Guatemala, Italy, Canada, Australia, Netherlands, Germany, United Kingdom, Spain, Czech (Rep), Nicaragua, China, Bangladesh, Morocco, Bolivia, Vietnam, Slovakia, Paraguay, Argentina, Turkey, Chile, Singapore, Japan, Colombia, Egypt, Hong Kong, Honduras, India, Croatia, Venezuela, Saudi Arabia, Greece, Hungary, Mexico, Austria, Ireland,Indonesia, Dominican Republic, Portugal, South Africa, Panama, Philippines, Libyan Jamahiriya, Jordan, Malaysia, France, Thailand, Peru, Costa Rica, Korea, and Taiwan.
Product description
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician.
Code information (models, lots, serial numbers)
Catalog Code 17310, 17311, 17312 (each of the affected devices is individually seralized)
Other devices under the same FDA submission
12 devices cleared under K013642, K073069, K103211 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AVEA 2 VENTILATOR 32029-001Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use1 death300 reports
- Revel 19260-001Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use5 reports
- AVEA™ 17312-24Vyaire Medical, Inc. · Ventilator, continuous, facility use4 reports
- AVEA™ 17310-00Vyaire Medical, Inc. · Ventilator, continuous, facility use4 reports
- Avea 17312-00Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use4 reports
- Avea 32029-001Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use4 reports
- AVEA 17220Vyaire Medical, Inc. · Ventilator, continuous, facility use3 reports
- AVEA II 32193-001Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use2 reports
- Vela 16530-00Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use1 report
- AVEA 50000-40033Carefusion Corporation · Ventilator, Continuous, Facility Use1 report
- AVEA 12283-PMNCarefusion Corporation · Ventilator, Continuous, Facility Use1 report
- AVEA II 32078-001Vyaire Medical, Inc. · Ventilator, Continuous, Facility Use1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page