Maquet Cardiopulmonary Gmbh: Device Recall

Recall #Z-2193-2025 · 06/27/2025

Class II: Risk

Recall Details

Recall Number: Z-2193-2025
Classification: Class II
Product Type: Device
Recalling Firm: Maquet Cardiopulmonary Gmbh
Status: Ongoing
Date Initiated: 06/27/2025
Location: Rastatt, Germany
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7,754 units

Reason for Recall

Device does not comply with the labeling requirements of international standard IEC 60601-1.

Product Description

Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.

Other Recalls by Maquet Cardiopulmonary Gmbh

Class II: Risk 01/09/2026

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.

View all recalls by Maquet Cardiopulmonary Gmbh →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.