FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular, LLC: AXIUS Blower Mister Product Code/REF Number: CB-1000 The Axius Blower Mister is intended to clear an anastomotic site for improved visibility
- Recall number
- Z-0983-2019
- 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
- Status
- Terminated
- Initiated
- 2019-01-24
- Posted
- not on file
- Terminated
- 2020-07-13
- Reason
- Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 96255605,96255607,96255608,96255609,96255611 UDI: 20607567700745
- 510(k) numbers
- ["K983135"]
- PMA numbers
- not on file
- Product code
- FQH
- Firm FEI
- 2242352
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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