Maquet Medical Systems USA BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Brand
Maquet Medical Systems USA
Lot Codes / Batch Numbers
UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070, 3000355577, 3000358977
Products Sold
UDI-DI 4037691530864 Lots 3000286570 and 3000325568 ***Lots added 3/21/24*** 3000341070; 3000355577; 3000358977
Maquet Medical Systems USA is recalling BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with a due to Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Nonconformities at their seal could potentially compromise the sterile barrier for affected products. Breach of sterile barrier could expose patients to pathogenic agents, resulting in the following potential harms: inflammation, infection, or sepsis.
Recommended Action
Per FDA guidance
On January 8, 2024, the firm notified affected customers via URGENT MEDICAL DEVICE Removal letters. Customers were instructed to remove all affected RF-32 pumps from use. If product is already in use, the firm advised to not discontinue therapy, but to monitor the patient closely for signs of infection. Customers should quarantine all affected product and return unopened/unexpired affected product to MCP/Getinge. Please contact MCP/Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to request a return authorization (RMA) number and shipping instructions. Distributors should forward the recall document to customers who received affected products. Information also posted on firm's website: https://www.getinge.com/us/products-and-solutions/cardiovascular-procedures/ ***Updated 3/21/24*** Firm expanded field action to include additional lots. Amended notifications were sent to affected US customers on March 20, 2024.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026