Quick Facts at a Glance
- Recall Date
- January 9, 2026
- Hazard Level
- HIGH
- Brand
- Maquet Cardiopulmonary Gmbh
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Maquet Cardiopulmonary Gmbh
- Product type
- Bubble Sensor
- Model numbers
- Model Number: 701055720, UDI-DI: 04037691816432, Serial Numbers: All units impacted
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 9, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
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
About This Product
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.
Why This Is Dangerous
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.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must discontinue use of the device to avoid potential malfunctions that could result in serious medical complications.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the device to confirm it is 701055720.
- Check for the UDI-DI number 04037691816432.
- Verify that your device has not been altered or damaged.
Where to find product info
The model number and UDI-DI can usually be found on the device's label or packaging.
What timeline to expect
Refund processing typically takes 4-6 weeks after following the recall instructions.
If the manufacturer is unresponsive
- Document your correspondence with the manufacturer.
- Consider reporting the issue to the FDA or consumer protection agencies.
- Reach out to your healthcare provider for assistance.
How to prevent similar issues
- When purchasing medical devices, ensure they have robust warranties.
- Check for recent recalls before buying any medical equipment.
- Look for devices with durable and flexible cable designs.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any documentation related to the recall for your records.
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Product Details
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.
Key Facts
- Recall date: January 9, 2026
- Report date: February 11, 2026
- Quantity recalled: 3,050 units
- Hazard classification: Class II
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