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

Recall number

Z-1300-2026

Recalling firm

Maquet Cardiopulmonary Gmbh

Product

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

Status

Open, Classified

Initiated

2026-01-09

Posted

2026-02-05

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

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 recallresponses.qrc@getinge.com. - Contact Customer Service via email at ACTSalesSupport.US@Getinge.com 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 ACTSalesSupport.US@Getinge.com 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).

Quantity

3050 units

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

Lot, serial or model codes

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

510(k) numbers

["K133598"]

PMA numbers

not on file

Product code

DTQ

Firm FEI

3009507273

Firm city

Rastatt

Firm state

not on file

Firm country

Germany

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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