Z-0678-2020Class II

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the...

Name: Z-0678-2020 Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the...
Creator: Maquet Cardiovascular Us Sales, Llc
Published: 2019-12-03
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2019-12-03 / Terminated / root cause: manufacturing process

FDA source

Maquet Cardiovascular Us Sales, Llc began a recall of Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console on 2019-12-03. FDA classified it as Class II and gives the reason as "A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console". 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-0678-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-03
Posted: 2019-12-12
Terminated: 2020-09-18
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.
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.
Root cause tag: manufacturing process
FDA 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 in commerce: 11 distributed in the US
Distribution: The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.
Product codes and lots: UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0678-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0678-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-18	2019-12-12

Product code KFM

K991864Class IIRotaflow Centrifugal Pump SystemJostra Medizintechnik AG / cleared 2000-08-31

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)