FDA recall, , Moderate risk
Maquet Cardiopulmonary Bubble Sensor
The Bubble Sensor has a durability issue with its connecting cable that can cause damage or loose contact.
Summary by Recall Canary from the FDA notice
What happened
Maquet Cardiopulmonary GmbH, based in Rastatt, Germany, recalled the Bubble Sensor for 3/8" x 3/32" tubing, Model Number 701055720, after internal investigations 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. The recall began on January 9, 2026, and was added to the FDA's Enforcement Report on February 5, 2026.
The product was distributed worldwide, including nationwide in the United States and internationally to numerous countries. The recall affects 3050 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the listed under your product.
701055720
Recall details
- Company began the recall
- Sold in
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
- Company
- Maquet Cardiopulmonary GmbhRastatt, Germany
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98159
- Recall number
- Z-1300-2026
- Quantity recalled
- 3050 units
All recalls from Maquet Cardiopulmonary Gmbh
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
