Agency classClass IOur severity:Severe FDA (Devices)·Z-0986-2019·Announced 2019-04-03

Maquet Cardiohelp Emergency Drive Recalled for Gearwheel Assembly Defect

Maquet Cardiovascular is recalling 10 units of the Cardiohelp Emergency Drive because the gearwheel may have been incorrectly reassembled, leading to inadequate operation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."

Plain-English summary

Maquet Cardiovascular US Sales, LLC is recalling 10 units of the Cardiohelp Emergency Drive, Part No. 70104.8002. The recall is due to a potential defect where the gearwheel may have been incorrectly reassembled during servicing, which could lead to inadequate operation of the device.

The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails. The affected units were distributed nationwide in the states of California, Florida, Illinois, Kentucky, Michigan, and New York. The specific affected serial numbers are: 90420359, 90421204, 90421188, 90421279, 90421228, 90421761, 90420904, 90420231, 90420455, and 90421304.

Healthcare facilities and users should check their inventory for these specific serial numbers. If the device is found, it should be removed from service and returned to Maquet Cardiovascular US Sales, LLC in accordance with the recall instructions.

The recalled product

Product: Cardiohelp Emergency Drive, Part No. 70104.8002 Product Usage: The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.
Manufacturer: Maquet Cardiovascular Us Sales, Llc
Category: Medical Device — Cardiovascular
Hazard: mechanical-defect
inadequate-operation
Affected units: 10

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 (10)

Affected serial numbers: 90420359
90421204
90421188
90421279
90421228
90421761
90420904
90420231
90420455
90421304

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Same manufacturer · Maquet Cardiovascular Us Sales, Llc

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