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FloProbe 3/8" x 3/8” (Sterile)
Movair, Inc. · Model 3080S · UDI-DI 00814321020186
DPT
Prescription
1
510(k) clearances
398
Adverse events (7 deaths)
24
Recalls
19
Facilities
Description
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
| 2024-09-24 | Smiths Medical ASD, Inc. | Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.