Maquet Cardiopulmonary Gmbh Recalls Bubble Sensors Over Cable Durability Concerns

Source: FDA · United States

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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 February 19, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

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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 ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
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.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.