The Recall Desk
HighFDA (Devices)·Z-1300-2026·Announced 2026-02-11

[pending] Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Pending LLM rewrite. Source: FDA_DEVICE Z-1300-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Manufacturer
Maquet Cardiopulmonary Gmbh

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number: 701055720
  • UDI-DI: 04037691816432
  • Serial Numbers: All units impacted

Distribution

Distributed nationwide across the United States.