Skip to content

MAQUET CARDIOHELP recallZ-0420-2024 · Maquet Medical Systems USA · initiated Oct 10, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Maquet Medical Systems USA or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0420-2024
Status
Open, Classified
Initiated by the company
Oct 10, 2023
Posted by the FDA
Dec 7, 2023
Recalling firm
Maquet Medical Systems USA
Quantity
Updated 1/8/24 - 1858 Total distributed in U.S.; 69 Total affected units in U.S.
Product code
DTQ
FDA submissions
K133598
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 description

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

Code information (models, lots, serial 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, 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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under K133598 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page