Use caution Medical device recall · FDA · Published February 8, 2019

Maquet Cardiohelp Emergency Drive Recall: Incorrect Reassembly Risk

Maquet recalls specific Cardiohelp Emergency Drive models due to potential incorrect reassembly during servicing, which may cause inadequate operation in emergencies. Affected serial numbers listed.

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

🇺🇸 FDA recall #Z-0986-2019Medical device Maquet ›

Use caution until it’s fixed

Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled incorrectly, leading to the inadequate operation of the Emergency Drive.

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 certain Cardiohelp Emergency Drive models because improper reassembly during servicing could lead to the device not working correctly in emergencies. This is serious because emergency medical devices must function reliably. Read more at govinfonow.com/recall/69031-maquet-cardiohelp-emergency-drive-recall-incorrect-reassembly-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/69031-maquet-cardiohelp-emergency-drive-recall-incorrect-reassembly-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0986-2019

Cite this page

“Maquet Cardiohelp Emergency Drive Recall: Incorrect Reassembly Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69031-maquet-cardiohelp-emergency-drive-recall-incorrect-reassembly-risk. Based on FDA recall #Z-0986-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0986-2019%22&limit=1).

Maquet Cardiovascular Us Sales, Llc recalled the Cardiohelp Emergency Drive due to potential inadequate operation caused by incorrect gearwheel reassembly. The Food and Drug Administration announced this Class I recall on February 8, 2019.

How to tell if you have it

Brand: Maquet
Product: Cardiohelp Emergency Drive
Part Number: 70104.8002
Affected serial numbers: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, 90421304

The hazard

The gearwheel in the Emergency Drive may have been re-assembled incorrectly during servicing. This defect can lead to the inadequate operation of the device.

Context

GovInfoNow's records show Maquet Cardiovascular Us Sales, Llc has 14 other recalls on record since October 25, 2018. Other recent recalls include a sterility barrier breach in the Maquet HLS Set Advanced 7.0 (November 20, 2020), a PCBA short creepage risk in the BMU 40 Blood Monitor (September 30, 2020), and an electric shock risk from exposed wiring in the Yuno II Mobile Operating Table (September 24, 2020).

How to tell if you have this one

Check the serial number on the device. Affected models include 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, and 90420455, 90421304.

Brand
Maquet
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Number
Look for the serial number on the device to confirm if it is one of the affected numbers listed.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 6 states.

FDA distribution: “US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Illinois, Kentucky, Michigan, New York.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

Feb 8, 2019Firm started the recall
Mar 28, 2019FDA classified it Class I
Apr 3, 2019Published in FDA’s Enforcement Report
May 14, 2020FDA terminated the recall

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

Similar recalls

Latest medical device recalls

Keep exploring

More Maquet recalls

Link to this recall

<a href="https://govinfonow.com/recall/69031-maquet-cardiohelp-emergency-drive-recall-incorrect-reassembly-risk">Maquet Cardiohelp Emergency Drive Recall: Incorrect Reassembly 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-0986-2019 (February 8, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0986-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.