Device, Anastomotic, Microvascular
FDA adverse event reports and recall history for device, anastomotic, microvascular (product code MVR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 591
- Deaths
- 0
- Injuries
- 146
- Malfunctions
- 439
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2008-08-02TerminatedDevice Design
GEM 2753 Microvascular Anastomotic Coupler, 2.5 mm, REF GEM2753/I, P/N 5111-00250-010, Rx only, Irradiation Sterilized This is a microsurgical coupler used in the anastomosis of veins and arteries normally encountered in microsurgical vascular reconstructive procedures.
Coupler rings may slip out of the delivery toolcaused by jaws larger than specification.
- Open, ClassifiedSoftware design
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable device for vascular use.
Potential for the battery to lose its ability to be recharged.
- TerminatedUnder Investigation by firm
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
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
- TerminatedUnder Investigation by firm
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
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
- TerminatedUnder Investigation by firm
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
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
- Open, ClassifiedDevice Design
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.
Monitor device, anastomotic, microvascular automatically
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