Device, Anastomotic, Microvascular
General, Plastic Surgery · 21 CFR 878.4300
Recent MDR events
601 adverse event reports on file
- GEM Microvascular Anastomotic COUPLERJul 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02486
- GEM Microvascular Anastomotic COUPLERJul 29, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02485
- GEM Microvascular Anastomotic COUPLERJul 28, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02469
- GEM Microvascular Anastomotic COUPLERJul 28, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02471
- GEM Microvascular Anastomotic COUPLERJul 27, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02412
- GEM Microvascular Anastomotic COUPLERJul 27, 2026InjuryBaxter Healthcare Corporation1416980-2026-02437
- GEM MICROVASCULAR ANASTOMOTIC COUPLERJul 22, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02408
- GEM MICROVASCULAR ANASTOMOTIC COUPLERJul 21, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02384
- GEM MICROVASCULAR ANASTOMOTIC COUPLERJul 10, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02286
- GEM MICROVASCULAR ANASTOMOTIC COUPLERJul 3, 2026MalfunctionBaxter Healthcare Corporation1416980-2026-02235
Event type breakdown
Recalls
6 recall events for this product code
- Synovis Micro Companies Alliance IncTerminatedAug 2, 2008
GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized
Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
Z-2138-2008 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedUnknown
FLOW COUPLER Monitor
Potential for the battery to lose its ability to be recharged.
Z-0939-2021 · View FDA record ↗ - Baxter Healthcare CorporationTerminatedUnknown
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurg
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
Z-1685-2020 · View FDA record ↗ - Baxter Healthcare CorporationTerminatedUnknown
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgi
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
Z-1686-2020 · View FDA record ↗ - Baxter Healthcare CorporationTerminatedUnknown
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures on
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
Z-1687-2020 · View FDA record ↗ - Baxter Healthcare CorporationOpen, ClassifiedUnknown
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Z-2474-2020 · View FDA record ↗
Registered firms
18 firms currently registered for this product code
510(k) clearances
9 clearances for this product code
- Baxter/ Synovis Micro Companies Alliance, Inc.Sep 6, 2019
K190499 · Gem FlowCoupler System
- Baxter/ Synovis Micro Companies Alliance, Inc.Jul 9, 2019
K191252 · Gem FlowCoupler System
- Synovis Life Technologies, Inc.Jan 16, 2015
K143589 · GEM Flow COUPLER Device and System
- Synovis Life Technologies, Inc.Sep 16, 2014
K142309 · GEM Flow COUPLER Device and System
- Synovis Life Technologies, Inc.Oct 22, 2013
K132727 · GEM FLOW COUPLER DEVICE AND SYSTEM
- Synovis Micro Companies Alliance, Inc.Feb 1, 2010
K093310 · GEM FLOW COUPLER DEVICE AND SYSTEM
- Vioptix, Inc.Apr 17, 2009
K090679 · VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM
- Synovis Micro Companies Alliance, Inc.Apr 16, 2004
K040163 · MICROVASCULAR ANASTOMOTIC DEVICE