Maquet Cardiopulmonary Gmbh recalled 3,050 Venous Bubble Sensors on January 9, 2026. Internal investigations revealed issues with the durability of the connecting cable. Excessive bending can lead to device failure, posing a risk to patient safety.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Maquet Cardiopulmonary Gmbh or your healthcare provider for instructions. Notification method: Letter
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The Venous Bubble Sensor monitors air bubbles in medical tubing, crucial for patient safety during procedures. Healthcare providers rely on this device to prevent air embolisms, which can be life-threatening.
The durability issue with the connecting cable may cause the device to malfunction, leading to incorrect readings or disconnections. This can compromise patient safety during critical medical procedures.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must discontinue use of the device to avoid potential malfunctions that could result in serious medical complications.
The model number and UDI-DI can usually be found on the device's label or packaging.
Refund processing typically takes 4-6 weeks after following the recall instructions.
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
The recall affects Venous Bubble Sensors, model number 701055720. The devices were distributed worldwide, including the U.S. and over 70 international countries. The product's unique device identifier (UDI-DI) is 04037691816432.
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