Maquet BMU 40 Blood Monitoring Units Recalled for Electrical Safety Non-Compliance
Maquet Cardiovascular is recalling 51 Blood Monitoring Units (BMU 40) because the printed circuit boards do not meet IEC electrical safety standards for creepage distance.
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 with a structural electrical safety defect (non-compliance with IEC creepage distance standards) which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 51 units of the Blood Monitoring Unit (BMU 40), model no. 701040852. These devices are used to monitor blood parameters, including oxygen pressure, temperature, saturation, hemoglobin, and hematocrit, during cardiopulmonary bypass or similar procedures with extracorporeal circulation.
The recall was initiated because the Printed Circuit Board Assembly (PCBA) in these units is not in compliance with the IEC 60601-1 standard (third edition). Specifically, the affected units were designed with a short creepage distance of 1.8 mm between two distinct and proximal areas on the printed circuit board, whereas the standard requires a creepage distance of 4 mm.
The affected units were distributed worldwide, including in the United States (AZ, CA, IA, MD, NC, PA, TX, WA, WI) and numerous international locations. Specific serial numbers are listed in the official recall documentation. Healthcare facilities and users should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Affected units
- 51
Distribution
Related recalls
Same manufacturer · Maquet Cardiovascular Us Sales, Llc
See all →- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breach
FDA (Devices) · 2020-12-23
- HighMaquet Cardiovascular Recalls HLS Set Advanced Due to Sterility Breaches
FDA (Devices) · 2020-12-23
- 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
- LowMaquet Rotaflow System Console Instructions for Use Recall
FDA (Devices) · 2020-09-23
Same hazard · electrical safety
See all →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- ModerateSpacelabs SL Command Module patient monitor recall due to manufacturing defect
FDA (Devices) · 2026-05-13
- High
- High
- ModerateMRI systems recalled over electrode spacing below the required safety standard
FDA (Devices) · 2025-11-05
Similar recalls
- ModerateMaquet Recalls Expired Hemofiltration Standard Packs for Cardiopulmonary Bypass
FDA (Devices) · 2018-02-07
- HighMaquet HCU 30 Heater-Cooler Unit Recalled for Power Supply Board Failure
FDA (Devices) · 2016-01-13
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Custom Tubing Kits
FDA (Devices) · 2018-06-20
- HighDatascope Recalls Maquet Cardiopulmonary Bypass Tubing Kits Due to Valve Defect
FDA (Devices) · 2018-06-20
- HighMaquet HCU 30 Heater-Cooler Units Recalled for Bacterial Contamination Risk
FDA (Devices) · 2016-11-09
- ModerateTerumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves
FDA (Devices) · 2015-07-01