FDA DevicesClass II
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Published: February 11, 2026Recall ID: Z-1300-2026Category: devicesCountry: US
Reason for Recall / Hazard
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.
Product Description & Identification
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Affected Products
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Additional Source Details
| Field | Value |
|---|---|
| City | Rastatt |
| State | N/A |
| Event id | 98159 |
| Address 1 | Kehler Str. 31 |
| Address 2 | N/A |
| Code info | Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted; |
| Postal code | N/A |
| Report date | 20260211 |
| Product type | Devices |
| Product quantity | 3050 units |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260109 |
| Initial firm notification | Letter |
| Center classification date | 20260205 |
Overview
- Recalling FirmMaquet Cardiopulmonary Gmbh
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam