FDA-Device2026-02-11Class IIPROCESSING DEFECT

Maquet Cardiopulmonary Venous Bubble Sensor recalled for cable durability defect

OTHERNationwide distributionMedical devices

What this means

Maquet Cardiopulmonary identified a durability problem with the connecting cable on its Venous Bubble Sensor (Model 701055720). Excessive bending of the cable can damage the sensor or loosen the connection, causing error messages on the connected medical device—either temporarily when the cable moves or permanently if the connection fails.

Inspect the connecting cable on your Maquet Venous Bubble Sensor (Model 701055720) for any signs of damage or wear, especially near the connection point.
Avoid excessive bending or movement of the connecting cable during use.
Contact Maquet Cardiopulmonary or your supplier for guidance on inspection, repair, or replacement if you have this model.
If you experience 'Ven. bubble sensor defective' or 'Ven. bubble sensor disconnected' errors, check the cable connection and contact your device manufacturer.

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The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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

Affected count

3050 units

Manufactured in

Kehler Str. 31, N/A, Rastatt, N/A, Germany

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2026

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