Maquet Cardiopulmonary Gmbh recalls Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Recall date

January 9, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1300-2026

FDA classification

Class II

Brand / firm

Maquet Cardiopulmonary Gmbh

Sold / distributed

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…

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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