Z-0420-2024Class I

CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood...

Name: Z-0420-2024 CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood...
Creator: Maquet Medical Systems USA
Published: 2023-10-10
License: https://open.fda.gov/license/

Maquet Cardiovascular Us Sales, LLC / initiated 2023-10-10 / Open, Classified

FDA source

Maquet Medical Systems USA began a recall of CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system on 2023-10-10. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0420-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-10-10
Posted: 2023-12-07
Recalling firm: Maquet Cardiovascular Us Sales, LLC
Product: CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: 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.
FDA 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 in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0420-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0420-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-12-13	2023-12-07

Product code DTQ

K133598Class IICardiohelp SystemMaquet Cardiopulmonary, AG / cleared 2014-05-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)