RotaFlow Centrifugal Pump Seal Defect Poses Infection Risk
Maquet Medical Systems is recalling 1,090 RotaFlow centrifugal pumps used in heart surgery due to seal defects that could compromise sterile barriers and expose patients to infection.
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 medical device recall involving products used in critical cardiovascular procedures. Although the potential harms—infection and sepsis—are serious, the source does not report any illnesses, injuries, or deaths. The harm is described as potential rather than confirmed, placing this in the high-risk category where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling 1,090 RotaFlow Centrifugal Pumps with BIOLINE Coating (Product Code 701047554) used in extracorporeal cardiovascular and cardiopulmonary bypass circuits. These pumps assist blood circulation during heart surgery and similar procedures.
The recalled pumps may have nonconformities at the seal that could potentially compromise the sterile barrier protecting patients from contamination. A breach could expose patients to pathogenic agents.
Potential harms from sterile barrier breach include inflammation, infection, or sepsis. The affected devices were distributed nationwide and internationally to Canada, Germany, Italy, Japan, and the Netherlands.
Affected lot numbers include 3000286570, 3000325568, 3000341070, 3000355577, and 3000358977.
The recalled product
- Product
- BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-breach
- infection
- sepsis
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)
- 3000355577
- 3000358977
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27