Home › Device types › MVR
Device, Anastomotic, Microvascular
FDA product code MVR · Class 2 · General, Plastic Surgery
20
Registered devices
601
Adverse events
6
Recalls
9
510(k) clearances
Devices with this code
GEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM VESSEL EVERTER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM FLOW COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM FLOW COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM FLOW COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM FLOW COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM FLOW COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INCGEM Microvascular Anastomotic COUPLER — SYNOVIS MICRO COMPANIES ALLIANCE, INC
Recent 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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