Maquet Cardiopulmonary Gmbh recalls Bubble Sensor for 3/8" x 3/32" tubing

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.

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

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).

• FDA enforcement recordOfficial FDA database entry for Z-1300-2026
• FDA 510(k) clearance · K133598The device's official FDA premarket clearance record
• FDA device classification · DTQOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.4220The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Maquet Cardiopulmonary GmbhSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.