Reported Apr 3, 2019 · Terminated

Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to…

Maquet Cardiovascular US Sales, LLC

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094

Is this the product you have?

  • Cardiohelp Emergency Drive, Part No. 70104.8002
  • Product UsageThe Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails
Lot codes and dates
  • Affected serial numbers
    • 90420359
    • 90421204
    • 90421188
    • 90421279
    • 90421228
    • 90421761
    • 90420904
    • 90420231
    • 90420455
    • 90421304
Amount recalled
10

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 14, 2020 · Data as of Sep 19, 7:35 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.