Maquet Medical Systems USA: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Recall number

Z-0420-2024

Recalling firm

Maquet Medical Systems USA

Product

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.

Status

Open, Classified

Initiated

2023-10-10

Posted

2023-12-07

Terminated

not on file

Reason

Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inappropriate low blood flow. Potential associated harms are ischemia and hypoxia.

Root cause

Under Investigation by firm

Action

On October 10, 2023, the firm issued an Urgent Medical Device Removal letter to all affected consignees. Customers should examine their inventory to determine if they have any affected CARDIOHELP Emergency Drives in their inventory. A representative from Getinge will contact customers to ensure they have received the recall information and have taken the necessary actions. Getinge will arrange the supply of loaner replacements where needed and arrange for the return of affected devices for repair. " You may also request loaner Emergency Drive(s) from Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) " If you have affected product that is currently being used in patient treatment, inform Getinge immediately at (888) 943-8872, option 1, option 1. Please ensure that an alternate means of emergency support is available at all times, which may include a nonaffected Emergency Drive (if available) or a fully charged backup CARDIOHELP console. If you have any questions, please contact Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). ***Updated 1/8/24*** Additional serial numbers were added to the scope.

Quantity

Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.

Distribution

US Nationwide - Worldwide Distribution: Domestic distribution to: AL, CA, DC, FL, HI, IA, IL, IN, KY, MD, MI, MN, MO, NE, OH, SC, VA Foreign distribution to: Austria, Australia, Brazil, Canada, Chile, China, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Jordan, Mexico, New Zealand, Pakistan, Portugal, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom

Lot, serial or model codes

Part No. 701048002: UDI - 04037691643526; Serial Numbers 90425259 to 90425748 (Excluding 90425438, 90425443, 90425568, 90425570, 90425588, 90425716) [***Updated 1/8/24 to include Serial numbers 90421507, 90421980, 90424277. Serial numbers 90425366 and 90423121 are additionally included in the scope due to internal complaints, but these units were corrected prior to the field action initiation and therefore are not included in customer notification***] Part No. 701076205: No UDI; Serial Numbers 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748

510(k) numbers

["K133598"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

3008355164

Firm city

Wayne

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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