BiDop 3Recalls & reported problems
Koven Technology, Inc. · Bidirectional Doppler with waveform display. · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Mar 4, 2026Open, Classified
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Z-1631-2026 · Root cause: Labeling Change Control · FDA record ↗
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- GEM FLOW COUPLER GEM2752 FCSynovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR4 reports
- GEM FLOW COUPLER GEM2753 FCSynovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR4 reports
- Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box 138660Vascular Technology, Incorporated · FLOWMETER, BLOOD, CARDIOVASCULAR1 report
- GEM FLOW COUPLER GEM2755 FCSynovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.