Class 2 Device Recall Maquet Bubble Sensor

• Date Initiated by Firm: January 09, 2026
• Date Posted: February 05, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1300-2026
• Recall Event ID: 98159
• 510(K)Number: K133598
• Product Classification: Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
• Product: Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720
• Code Information: Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted
• FEI Number: 3009507273
• Recalling Firm/ Manufacturer: Maquet Cardiopulmonary Gmbh; Kehler Str. 31; Rastatt Germany
• Manufacturer Reason for Recall: 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 Determined 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 in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DTQ