Bubble Sensor for 3/8" x 3/32" tubing recall (Maquet Cardiopulmonary Gmbh)
Medical deviceClass IIOngoing
Summary: Maquet Cardiopulmonary Gmbh is recalling Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;. 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.
What is being recalled
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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
How to tell if yours is affected
Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1300-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 9, 2026 |
| Reported | February 11, 2026 |
| Company | Maquet Cardiopulmonary Gmbh |
| Company location | Rastatt, N/A, Germany |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3050 units |
More recalls from Maquet Cardiopulmonary Gmbh · all medical device recalls · recalls from January 2026