Use caution Medical device recall · FDA · Published September 30, 2020

Maquet BMU 40 Blood Monitor Recall: PCBA Short Creepage Risk

Maquet recalls BMU 40 blood monitoring units with model 701040852 due to insufficient PCB creepage distance (1.8mm vs required 4mm), potentially causing electrical issues during cardiac surgery.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0443-2021Medical device Maquet ›

Use caution until it’s fixed

The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

Take action

Contact the company

Recalling firmMaquet Cardiovascular Us Sales, Llc45 Barbour Pond Dr · Wayne, NJ 07470-2094

✎ GovInfoNow plain-language explainer

Maquet is recalling blood monitoring units (BMU 40) with model number 701040852 because their printed circuit board has a dangerously short electrical gap (1.8mm instead of 4mm required). This could cause electrical faults during critical cardiac surgery procedures, putting patients at risk of injury. Read more at govinfonow.com/recall/64136-maquet-bmu-40-blood-monitor-recall-pcba-short-creepage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/64136-maquet-bmu-40-blood-monitor-recall-pcba-short-creepage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0443-2021

Cite this page

“Maquet BMU 40 Blood Monitor Recall: PCBA Short Creepage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64136-maquet-bmu-40-blood-monitor-recall-pcba-short-creepage-risk. Based on FDA recall #Z-0443-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0443-2021%22&limit=1).

The FDA announced on 2020-09-30 that Maquet Cardiovascular Us Sales, Llc is recalling the Blood Monitoring Unit (BMU 40), model no. 701040852, due to non-compliance with IEC standards regarding creepage distance on the printed circuit board assembly.

How to tell if you have it

Brand: Maquet
Product: Blood Monitoring Unit (BMU 40)
Model no.: 701040852
Serial numbers: 90002022, 90002134, 90002163, 90002187, 90002276, 90002297, 90002023, 90002135, 90002164, 90002188, 90002277, 90002298, 90002024, 90002136, 90002168, 90002191, 90002279, 90002302, 90002029, 90002137, 90002170, 90002194, 90002280, 90002306, 90002047, 90002140, 90002172, 90002195, 90002281, 90002312, 90002112, 90002143, 90002181, 90002196, 90002287, 90002313, 90002123, 90002144, 90002183, 90002210, 90002289, 90002124, 90002160, 90002184, 90002212, 90002293, 90002133, 90002161, 90002185, 90002273, 90002296
Units affected: 51

The hazard

According to the FDA, the Printed Circuit Board Assembly (PCBA) in the BMU 40 units has a short creepage distance of 1.8 mm between two distinct and proximal areas on the printed circuit board, whereas the IEC standard (60601 1, third edition) requires a creepage distance of 4 mm.

Context

GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since 2018-10-25. Other recent recalls include the Maquet HLS Set Advanced 7.0 Recall (2020-11-20) for sterility barrier breaches and the Maquet Yuno II Mobile Operating Table Recall (2020-09-24) for electric shock risk from exposed wiring. Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System Recall (2025-12-15) and the Philips Allura Xper FD10F Medical System Recall (2025-12-15), both citing risk of electrical short-circuits.

How to tell if you have this one

Check for the model number 701040852 on the BMU 40 blood monitoring unit. The units were sold with serial numbers starting from 90002022 through 90002313.

Brand
Maquet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Unit Serial Number
Identify the serial number on your BMU 40 unit to confirm if it's in the affected range (90002022 to 90002313).
Contact Manufacturer
Reach out to Maquet Cardiovascular US Sales, LLC for further instructions on how to address the issue.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 9 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France, Germany,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, California, Iowa, Maryland, North Carolina, Pennsylvania, Texas, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Sep 30, 2020Firm started the recall
Nov 12, 2020FDA classified it Class II
Nov 18, 2020Published in FDA’s Enforcement Report
May 25, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/64136-maquet-bmu-40-blood-monitor-recall-pcba-short-creepage-risk">Maquet BMU 40 Blood Monitor Recall: PCBA Short Creepage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0443-2021 (September 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0443-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.