GEM Microvascular Anastomotic COUPLER GEM2751 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844735002614), received between Aug 27, 2024 and Aug 6, 2025 — classified as 1 injury, 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
- Device Dislodged or Dislocated1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RINGS OF A 1.5MM COUPLER OPENED A FEW SECONDS AFTER BEING EJECTED BY THE COUPLER APPLICATOR DURING A PATIENT SURGERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 22734384 ↗MalfunctionAug 27, 2024Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent
IT WAS REPORTED THE ANASTOMOSIS RING NEEDLE HOLES OF AN UNSPECIFIED QUANTITY OF 1.5MM COUPLER WERE MISALIGNED AND THE NEEDLES APPEARED BENT. THE EVENTS OCCURRED DURING ¿NORMAL SURGICAL 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 20075212 ↗
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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