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GEM FLOW COUPLER MONITOR
SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM1020M-2 · UDI-DI 00844735006148
DPW
Prescription
1
510(k) clearances
75
Adverse events
35
Recalls
43
Facilities
Description
The Flow COUPLER Monitor is a pulsed Doppler ultrasound system designed to detect vessel blood flow and confirm vessel patency intra and post-operatively at the anastomotic site as needed up to 7 days.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-04 | Koven Technology, Inc. | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |
| 2025-09-26 | Medistim Asa | Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer S |
| 2025-08-07 | Flosonics Medical (R/A 1929803 ONTARIO CORP.) | Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20. |
| 2023-06-19 | Baxter Healthcare Corporation | An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B |
| 2018-06-19 | Vascular Technology, Inc. | Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver |
| 2017-04-25 | Medistim Asa | A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
| 2016-04-21 | Baxter Healthcare Corp. | Instructions for use booklet may puncture the outer Tyvek lid. |
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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.