The Recall Desk

FDA (Devices) recall action 93852

Maquet Medical Systems USA recalled 2 products on 2024-02-14

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2024-02-14
Critical
0
Units
2,180

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2024-02-14

    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.

    Product
    BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Distribution
    12 states
  • HighFDA (Devices)··2024-02-14

    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.

    Product
    BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
    Category
    Distribution
    12 states