FloPump FloPump (Non-Sterile)Recalls & reported problems
Movair, Inc. · The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00814321020001), received between May 27, 2016 and Jun 2, 2016 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Pumping Problem1
Patient problems
- Hemolysis1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2016Improper or Incorrect Procedure or Method
PER CUSTOMER INFORMATION, THE PRODUCT CAUSED HIGH HEMOLYSIS IN A PATIENT. ACCORDING TO USER, DEVICE WAS BEING USED FOR EXTENDED PERIOD OF TIME, LONGER THAN SIX (6) HOURS.
Patient problems: Hemolysis
MAUDE report 5695256 ↗MalfunctionMay 27, 2016Pumping Problem; Pumping Problem
PER CUSTOMER COMPLAINT REPORT, THE FLOPUMP CONTAINED CRACKS ON THE BASE OF THE PRODUCT. THIS WAS NOTICED DURING RECEIVING INSPECTION BY THE CUSTOMER AND NOT DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5685313 ↗
Other Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type devices
- CENTRIMAG MOTOR 102956Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type2 recalls4 deaths591 reports
- Impella Impella 5.0 AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls56 deaths256 reports
- CentriMag™ 102953Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 recall35 deaths209 reports
- Impella Impella LD AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls9 deaths57 reports
- NA HY8M65R2Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE4 recalls0 reports
- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
- Custom Perfusion System BB6U40R11Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls1 report
- NA BB8C33R6Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page