GEM Microvascular Anastomotic COUPLER GEM2754 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00844735002676), received between Oct 23, 2020 and Apr 14, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
- Difficult to Open or Close2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2026Difficult to Open or Close
IT WAS REPORTED THAT TWO (2) 3.0MM COUPLERS RING MAY OPEN OR FAIL TO MAINTAIN ITS PROPER CLOSURE DURING HANDLING, PREVENTING CORRECT COUPLING OF THE SYSTEM. THIS OCCURRED DURING SURGICAL PROCEDURES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875093 ↗MalfunctionApr 14, 2026Difficult to Open or Close
IT WAS REPORTED THAT FOUR (4) 3.0MM COUPLERS RING MAY OPEN OR FAIL TO MAINTAIN ITS PROPER CLOSURE DURING HANDLING, PREVENTING CORRECT COUPLING OF THE SYSTEM. THIS OCCURRED DURING SURGICAL PROCEDURES. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24875092 ↗MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RINGS OF TWO (2) 3.0MM COUPLERS OPENED AFTER BEING EJECTED BY THE COUPLER APPLICATOR. THIS WAS OBSERVED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737787 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THAT A MICROVASCULAR ANASTOMOTIC COUPLER DEVICE WAS DAMAGED. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿IT SNAPPED¿. THIS OCCURRED INTRA-OP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20857964 ↗MalfunctionOct 23, 2020Break; Break
IT WAS REPORTED THAT A 3.0MM COUPLER DEVICE HAD ONE SIDE OF THE WING JAW THAT WAS BROKEN; FURTHER DESCRIBED AS A BROKEN TIP. THIS WAS IDENTIFIED DURING PREPARATION FOR SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Patient Involvement
MAUDE report 10730834 ↗
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 GEM2750Synovis Micro Companies Alliance, Inc · Device,anastomotic,microvascular3 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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