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GEM VESSEL EVERTER
SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM2742 · UDI-DI 00844735006179
MVR
Prescription
1
510(k) clearances
604
Adverse events
6
Recalls
4
Facilities
Description
The Vessel Everter System is used with the GEM COUPLER and Flow Coupler devices to press vessel tissue onto the GEM Flow Coupler/COUPLER rings, and to measure the vessel, if needed.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-12-28 | Baxter Healthcare Corporation | Potential for the battery to lose its ability to be recharged. |
| 2020-06-02 | Baxter Healthcare Corporation | A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 | Baxter Healthcare Corporation | The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2008-05-14 | Synovis Micro Companies Alliance Inc | Coupler rings may slip out of the delivery toolcaused by jaws larger than specification. |
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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.