GEM Microvascular Anastomotic COUPLER GEM2750 IRecalls & 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
All models of GEM Microvascular Anastomotic COUPLER (13)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844735002591), received between Aug 26, 2024 and Aug 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ANASTOMOSIS RINGS OF TWO (2) 1.0MM COUPLERS DETACHED. THE ISSUE WAS FURTHER DESCRIBED AS, "COULD NOT ACHIEVE PROPER ANASTOMOSIS". THIS OCCURRED PRIOR TO PATIENT USE. TO RESOLVE THE EVENT, THE SURGEON PERFORMED THE ANASTOMOSIS MANUALLY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20065870 ↗
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 Microvascular Anastomotic COUPLER GEM2753 ISynovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular6 reports
- GEM FLOW COUPLER GEM2754 FCSynovis 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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