Maquet ROTAFLOW Drive Recalled for Loose Cable Connection
Maquet is recalling 11 ROTAFLOW Drive units because a loose cable connection may cause fluctuating flow values on the console.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a defect may lead to inaccurate flow readings, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 11 units of the Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. This device is a component of the ROTAFLOW System Console. The recall was initiated because a loose ODU plug or coaxial cable connection may result in fluctuating flow values displayed on the console.
The affected products were distributed to the following US states: Maine, Nevada, New York, Ohio, Pennsylvania, Texas, and Virginia. The recall number is Z-0678-2020. The UDI is 04037691258997, and the affected serial numbers are 9348936, 910114412, 910114420, 910114429, 910114430, 910114432, 910114435, 910114438, 910117243, 91064722, and 91067680.
Healthcare facilities should contact Maquet Cardiovascular US Sales, LLC for instructions on how to address the issue. The source text does not report any injuries or illnesses associated with this recall.
The recalled product
- Product
- Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Category
- Medical Device — Cardiopulmonary
- Hazard
- Affected units
- 11
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 04037691258997
Distribution
Related recalls
Same manufacturer · Maquet Cardiovascular Us Sales, Llc
See all →- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
FDA (Devices) · 2020-12-23
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
FDA (Devices) · 2020-11-18
- HighMaquet Yuno II Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
- HighMaquet Yuno Mobile Operating Table Recalled for Electric Shock Risk
FDA (Devices) · 2020-10-28
Same hazard · inaccurate reading
See all →- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
- HighMidmark IQvitals Zone Recalled for Inaccurate Blood Pressure Readings
FDA (Devices) · 2026-09-30
Similar recalls
- LowMaquet Rotaflow System Console Instructions for Use Recall
FDA (Devices) · 2020-09-23
- HighMaquet Cardiopulmonary Sets Recalled Due to Incorrect Quick Connector Assembly
FDA (Devices) · 2019-09-25
- HighMaquet Rotaflow Centrifugal Pump Tubing Recalled for Endotoxin Risk
FDA (Devices) · 2016-04-20
- HighMaquet Getinge ROTAFLOW Support Pack Recalled for Sterility Assurance Concerns
FDA (Devices) · 2019-06-05
- HighMaquet Getinge Rotaflow Pack Recall Due to Sterility Assurance Concerns
FDA (Devices) · 2019-06-05
- HighMaquet Getinge Rotaflow Pack Recalled Due to Sterility Assurance Concerns
FDA (Devices) · 2019-06-05