Recall Z-1300-2026— Maquet Cardiopulmonary Gmbh
Class II · Ongoing
Class II FDA medical device recall by Maquet Cardiopulmonary Gmbh, initiated 2026-01-09. It names one FDA 510(k) clearance: K133598. Product: Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;. Reason: 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..
- Recalling firm
- Maquet Cardiopulmonary Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-09
- Firm location
- Rastatt, N/A, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.