Skip to content

MAQUET CARDIOHELP recallZ-1300-2026 · Maquet Cardiopulmonary Gmbh · initiated Jan 9, 2026

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 Cardiopulmonary Gmbh 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

Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

FDA root cause category: Under Investigation by firm

What the company is doing

On or around January 9, 2026, "URGENT MEDICAL DEVICE RECALL" letters were sent to customers. Customers were instructed to take the following actions: - Please examine your inventory immediately to determine if you have any affected product in your inventory and utilize the recommended mitigations listed above until replacement sensors are available. - Complete and return the enclosed response form Getinge by e-mailing a copy to [email protected]. - Contact Customer Service via email at [email protected] or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to order a replacement sensor that will be shipped once available. Affected sensors will be returned to Getinge at time of replacement. - Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. If you have any questions, contact Customer Service via email at [email protected] or 888-943-8872, ext 28849 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone).

Recall details

Recall number
Z-1300-2026
Status
Open, Classified
Initiated by the company
Jan 9, 2026
Posted by the FDA
Feb 5, 2026
Recalling firm
Maquet Cardiopulmonary Gmbh
Quantity
3050 units
Product code
DTQ
FDA submissions
K133598
Distribution
Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam

Product description

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Code information (models, lots, serial numbers)

Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;

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