RotaFlow Centrifugal Pump sterile barrier defect FDA Class II recall
RotaFlow Centrifugal Pumps have potential seal defects that could compromise sterile barriers, risking infection in cardiac bypass patients. FDA recommends device identification and contact with manufacturer for remediation.
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: This is an FDA Class II recall of a high-risk cardiac bypass device with a potential sterile-barrier breach that could expose patients to infection or sepsis. No illnesses, injuries, or deaths have been reported, and the hazard remains theoretical, placing it at the maximum severity for unconfirmed harms.
Plain-English summary
The FDA has issued a Class II recall for the BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating (Product Code 701047553) manufactured by Maquet Medical Systems USA. This device is used in extracorporeal cardiovascular and cardiopulmonary bypass circuits during cardiac surgery.
Nonconformities have been identified at the device's seal that could potentially compromise the sterile barrier. If the barrier is breached, patients could be exposed to pathogenic agents, potentially resulting in inflammation, infection, or sepsis.
Approximately 1,090 units have been distributed nationwide across 13 U.S. states (California, Illinois, Maryland, Missouri, North Carolina, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, and Virginia) and internationally to Canada, Germany, Italy, Japan, and the Netherlands. The affected lots are 3000283239, 3000330438, 3000334430, 3000344495, and 3000351245 (identified by UDI-DI 4037691650326).
The recalled product
- Product
- BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
- Manufacturer
- Maquet Medical Systems USA
- Category
- Medical Device
- Hazard
- sterile-barrier-breach
- infection-risk
- sepsis-risk
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 (2)
- 3000344495
- 3000351245
Distribution
Distributed nationwide across the United States.
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