Maquet Cardiopulmonary Gmbh Recalls Bubble Sensors Over Cable Durability Concerns

What Happened

Maquet Cardiopulmonary Gmbh has initiated a voluntary recall of certain bubble sensors following internal investigations that identified a durability issue. The connecting cable near the Venous Bubble Sensor is susceptible to damage from excessive bending. This can lead to a loose cable contact or full failure of the sensor, triggering error messages such as “Ven. bubble sensor defective” or “Ven. bubble sensor disconnected” on the connected medical device. These errors may occur intermittently when the cable is moved or become permanent if the connection is fully compromised.

Which Products Are Affected

The recall affects 3,050 units distributed worldwide, including nationwide across the United States.

• Product Name: Bubble Sensor for 3/8” x 3/32” tubing
• Model Number: 701055720
• UDI-DI: 04037691816432
• Serial Numbers: All units are impacted
• Recall Number: Z-1300-2026

What You Should Do

The recalling firm, Maquet Cardiopulmonary Gmbh, initiated notification to customers via a formal letter on January 9, 2026. Healthcare facilities and providers using these sensors should monitor for the specific error messages mentioned above. If the “Ven. bubble sensor defective” or “Ven. bubble sensor disconnected” alerts appear, the device’s connection may be compromised. Users should follow the instructions provided in the firm’s notification letter regarding the management of affected units.

Why This Matters

A malfunctioning bubble sensor can fail to properly monitor medical tubing, potentially leading to undetected issues or interruptions during critical medical procedures. This Class II recall indicates that the product defect could cause temporary or medically reversible adverse health consequences.

Source

This information is based on official recall data provided by the FDA.