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

Recalling company

Maquet Cardiopulmonary Gmbh

Product

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 9, 2026

Reported

Feb 11, 2026

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

Status

Ongoing

Quantity

3050 units

Lot / codes

Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;

Company location

Rastatt, N/A

Recall type

Voluntary: Firm initiated

Recall number

Z-1300-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1300-2026 in the FDA Enforcement Report. Also see FDA recall press releases.