Recall Z-1300-2026 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Maquet Cardiopulmonary Gmbh
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
| Date | Feb 5, 2026 (initiated Jan 9, 2026) |
| Status | Open, Classified |
| 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 Frida |
| 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, E |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133598 | CARDIOHELP SYSTEM Maquet Cardiopulmonary, AG, May 21, 2014 |