Maquet Cardiopulmonary Gmbh Recalls Bubble Sensors Over Cable Durability Concerns
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Maquet Cardiopulmonary Gmbh has issued a voluntary recall for 3,050 bubble sensors due to a cable defect that can cause the sensor to fail or disconnect during medical use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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.
Original source: FDA Official Notice ↗
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