GEM Microvascular Anastomotic COUPLER GEM2750Recalls & reported problems
Synovis Micro Companies Alliance, Inc · The GEM Microvascular Anastomotic COUPLER Device rings are made of polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. The GEM Microvascular Anastomotic COUPLER Device is single-use and available in various sizes · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844735002607), received between Aug 30, 2021 and Sep 2, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573298 ↗MalfunctionSep 2, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572840 ↗MalfunctionAug 30, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT A PIN OF A 1.0MM COUPLER - 6/BX WAS FOUND DEFORMED. THE ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12383459 ↗
Other Device,anastomotic,microvascular devices
- GEM Microvascular Anastomotic COUPLER GEM2753Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular44 reports
- GEM Microvascular Anastomotic COUPLER GEM2754Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular28 reports
- GEM Microvascular Anastomotic COUPLER GEM2755Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular13 reports
- GEM Microvascular Anastomotic COUPLER GEM2751Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular13 reports
- GEM Microvascular Anastomotic COUPLER GEM2752Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular10 reports
- GEM FLOW COUPLER GEM2754 FCSynovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular6 reports
- GEM Microvascular Anastomotic COUPLER GEM2753 ISynovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular6 reports
- GEM Microvascular Anastomotic COUPLER GEM2754 ISynovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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