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

Company / brand

Maquet Cardiopulmonary Gmbh

Product

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

Reason / hazard

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

Status

Ongoing

Distribution / sold at

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

Recall initiated

2026-01-09

Code info

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

Product quantity

3050 units

Voluntary mandated

Voluntary: Firm initiated

City

Rastatt

State

N/A

Country

Germany

Event id

98159

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