FDA Medical Device Recalls (openFDA)
Maquet Inc.: Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
- Recall number
- Z-3084-2011
- Recalling firm
- Maquet Inc.
- Product
- Maquet HL Console for Heart Lung Machine HL20 HL 20 4-pumps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751 Intended for use as an extracorporeal circulation device for perfusion lasting not more than six hours. The HL console is equipped with a rack for accommodating the system's electronic modules.
- Status
- Terminated
- Initiated
- 2011-06-20
- Posted
- 2011-08-29
- Terminated
- 2012-10-16
- Reason
- Maquet HL 20 Twin Pump Modules may unintentionally increase speeds for a 1.5-2 second period of time before returning to its original speed.
- Root cause
- Device Design
- Action
- Maquet sent a PRODUCT RECALL NOTIFICATION LETTER/return response forms, dated June 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of the affected product until a software update was performed by their trained technicians. Customers were also asked to forward the information contained in the notification letter to all users and to all appropriate Biomedical Staff. Customers were instructed to acknowledge receipt of the notification letter by completing and faxing back the attached response form to 973-807-9210 whether or not they have any of the affected product. For questions customers were instructed to contact their local MAQUET representative. For questions regarding this recall call 973-709-7994.
- Quantity
- 299 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 510K Number: K943803 Device Listing No.E614811 HL 20 4-umps console base: P/N 917741 HL 20 5-pumps console base: P/N 917751
- 510(k) numbers
- ["K943803"]
- PMA numbers
- not on file
- Product code
- DTQ
- Firm FEI
- 3008355164
- 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