Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Summary
The FDA issued a Class II for Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720; by Maquet Cardiopulmonary Gmbh. Reason: Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessiv.
Details
Source
Device Recall
External ID
Z-1300-2026
Action Date
2026-02-11
Status
Ongoing
Category
device
Product Description
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Lot/Code Info: Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;
Quantity Affected: 3050 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2026-01-09
Company
Rastatt, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 207 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Maquet Cardiopulmonary Gmbh has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Maquet Cardiopulmonary Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Maquet Cardiopulmonary Gmbh have FDA actions?
Maquet Cardiopulmonary Gmbh has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1300-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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