Z-0983-2019Class II

AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an...

Name: Z-0983-2019 AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an...
Creator: Maquet Cardiovascular, LLC
Published: 2019-01-24
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2019-01-24 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility on 2019-01-24. FDA classified it as Class II and gives the reason as "Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0983-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-24
Posted: 2019-03-07
Terminated: 2020-07-13
Recalling firm: Maquet Cardiovascular LLC
Product: AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
Product code: FQH Lavage, Jet
Reason for recall: Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm, Maquet/Getinge, issued "URGENT MEDICAL DEVICE RECALL - REMOVAL" letters mailed to customers on January 24, 2019 via FedEx Priority Overnight,. The letters identified the issue, the product, actions to take and health risk. The customers were instructed to:Please examine your inventory immediately to determine if you have any of the affected; stop using the affected lot numbers of the Axius Blower Mister; remove and properly label any identified affected product, and keep it in quarantine in a secure location to preclude being used. Should you have un-used affected product you are eligible for either a replacement or credit. Please contact Geting Customer Service at 1-888-627-8383 (press option 2, then option 4) to request a return authorization (RMA) and shipping instructions to return any affected product. Complete and sign the MEDICAL DEVICE RECALL - REMOVAL RESPONSE FORM to acknowledge that you have received this notification. Return the completed form to Maquet/Getinge by e-mailing a scanned copy to blowermister(@qetinge.com or by faxing the form to 1-800-915-0124. If you are a distributor who has shipped any affected products to customers, please forward this document to their attention for appropriate action. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at 1-888-627-8383 (press option 2, then option 4), Monday through Friday from 6:00 a.m. and 5:00 p.m. PST.
Quantity in commerce: 7,880 each (1,576 packs of 5)
Distribution: Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.
Product codes and lots: Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0983-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0983-2019	Class II	Terminated	Voluntary: Firm initiated	2019-03-13	2019-03-07

Product code FQH

K983135Class IIBlower/misterCardiothoracic Systems, Inc. / cleared 1998-11-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)