Maquet Cardiopulmonary Gmbh: Device Recall
Recall #Z-1300-2026 · 01/09/2026
Recall Details
- Recall Number
- Z-1300-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Maquet Cardiopulmonary Gmbh
- Status
- Ongoing
- Date Initiated
- 01/09/2026
- Location
- Rastatt, N/A, Germany
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 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.
Product Description
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Distribution Pattern
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
Other Recalls by Maquet Cardiopulmonary Gmbh
- Class II: Risk 06/27/2025