International Biophysics Corp IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio-Console System. The Medtronic Bio-Console System is intended for use in the monitoring of the extracorporeal cardiopulmonary bypass circuit blood flow rate during open heart surgery. part #3080N; packaged 10 per carton; International Biophysics Corp., Austin, TX.
Brand
International Biophysics Corp
Lot Codes / Batch Numbers
Lot #122004-100217 and #030805-100279.
Products Sold
Lot #122004-100217 and #030805-100279.
International Biophysics Corp is recalling IBC FloProbe (Non-sterile), a disposable flow probe that is used as a component of the Medtronic Bio due to Complaints received regarding the device's failure to zero out.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Complaints received regarding the device's failure to zero out.
Recommended Action
Per FDA guidance
Firm notified customers via e-mail and phone calls starting on 04/22/05.
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