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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
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, Serial Numbers 90425438, 90425443, 90425568, 90425570, 90425588, 90425716, 90425747, 90425748
Products Sold
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
Maquet Medical Systems USA is recalling CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood o due to Product removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to inapprop. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026