CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Bubble Sensor for 3/8" x 3/32" tubing recalled by Maquet Cardiopulmonary

Maquet Cardiopulmonary is recalling Bubble Sensor for 3/8" x 3/32" tubing, distributed nationwide in the US. The recall was initiated on 9 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;

Quantity recalled3050 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1300-2026
FDA event ID: 98159
Recalling firm: Maquet Cardiopulmonary, Rastatt, N/A
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jan 2026
FDA classified: 5 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

9 Jan 2026	Recall initiated by company
5 Feb 2026	Classified by FDA	+27 days
11 Feb 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was 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, 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

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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