FDA Medical Device Recalls (openFDA)
Maquet Cardiovascular Us Sales, Llc: Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
- Recall number
- Z-0678-2020
- Recalling firm
- Maquet Cardiovascular Us Sales, Llc
- Product
- Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
- Status
- Terminated
- Initiated
- 2019-12-03
- Posted
- not on file
- Terminated
- 2020-09-18
- Reason
- A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
- Root cause
- Nonconforming Material/Component
- Action
- An Urgent Medical Device Recall notification letter dated 12/3/19 was sent to customers. If your affected RFD unit is in clinical use, switch to RPM mode. Using hospital patient management protocols and physician judgement, perform the following steps: 1. Check your inventory for an unaffected RFD unit . If an unaffected RFD unit is available, it should be at the clinicians discretion to transfer the patient from the affected unit to the unaffected unit. 2. If an unaffected RFD unit is unavailable or if temporary interruption of extracorporeal blood flow is not possible check the following options: a. Please check your inventory for an independent external flow measurement system to measure the actual flow. Only use a reliable external flow measurement that is gauged and zeroed. Use that measurement system in conjunction with the RPM mode. If necessary adjust the RPM according to the flow reading as obtained with the independent external flow measurement system. A continuous control of the patient vital signs monitoring is indicated. If the the Bubble Sensor intervention is already active, leave the setting in place. b. In case no external flow measurement system is available stay on RPM mode and continuously control vital signs monitoring. It is indicated to closely monitor the blood gases of the respective patient. The assessment of the vital sign monitoring and the blood gas analysis in conjunction with the indicated pump speed (RPM) is required. If the the Bubble Sensor intervention is already active, leave the setting in place. 3. When treatment of patient is completed, remove your affected RFD unit from use and follow the Actions to be Taken for return and repair below. If your affected RFD unit is not in clinical use, remove your affected RFD unit and follow the Actions to be Taken for return and repair below. Actions to be taken 1. Our records indicate that you have received a Rotaflow Drive Unit with a serial number that is affected by this
- Quantity
- 11 distributed in the US
- Distribution
- The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
- Lot, serial or model codes
- UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680
- 510(k) numbers
- ["K991864"]
- PMA numbers
- not on file
- Product code
- KFM
- 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