GEM COUPLER Microvascular Anastomotic Instrument GEM2740Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00844735005233), received between Apr 21, 2026 and Apr 21, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Jam” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Mechanical Jam

  IT WAS REPORTED THAT A GEM COUPLER MICROVASCULAR ANASTOMOTIC INSTRUMENT PRESENTED AN ABNORMAL RESISTANCE ("SLIGHT SNAGGING") PRIOR TO BREAST RECONSTRUCTION SURGERY. THE DEVICE WAS RETURNED FOR LUBRICATION AND RESTERILIZATION, AND A SECOND VEIN COUPLER WAS OPENED AS A BACKUP; BOTH WERE AVAILABLE FOR USE PRIOR TO SURGERY. DURING VEIN TO VEIN ANASTOMOSIS, NEITHER INSTRUMENT FUNCTIONED AS INTENDED, AS THE USER WAS UNABLE TO CONNECT THEM TO THE DISPOSABLE COUPLER COMPONENTS. THE USER REMARKED THAT THERE WAS "SOMETHING WRONG WITH THE INTERNAL SPRING MECHANISM", AND THEY COULD VISUALLY OBSERVE THAT SOMETHING WAS OBSTRUCTING IT. MULTIPLE DISPOSABLE COMPONENTS WERE ATTEMPTED WITHOUT SUCCESS. AN OLDER COUPLER INSTRUMENT (ANASTOMOTIC INSTRUMENT) WAS SUBSEQUENTLY USED BUT DEMONSTRATED SIGNIFICANT RESISTANCE. ALTHOUGH AN ANASTOMOSIS WAS ACHIEVED, AN ANASTOMOTIC LEAK WAS DETECTED, REQUIRING A NEW ANASTOMOSIS. DUE TO VESSEL SHORTENING, ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. PART OF THE RIB HAD TO BE RESECTED, DURING WHICH A CUT OCCURRED AND SIGNIFICANT HEMORRHAGE FROM THE INTERNAL MAMMARY ARTERY HAPPENED. THE SURGEON CLAMPED THE "BLEEDING" PREVENTING ANY MAJOR BLOOD LOSS. DURING SUCH COMP

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 24947629 ↗
• InjuryApr 21, 2026Mechanical Jam

  IT WAS REPORTED THAT A GEM COUPLER MICROVASCULAR ANASTOMOTIC INSTRUMENT PRESENTED AN ABNORMAL RESISTANCE ("SLIGHT SNAGGING") PRIOR TO BREAST RECONSTRUCTION SURGERY. THE DEVICE WAS RETURNED FOR LUBRICATION AND RESTERILIZATION, AND A SECOND VEIN COUPLER WAS OPENED AS A BACKUP; BOTH WERE AVAILABLE FOR USE PRIOR TO SURGERY. DURING VEIN TO VEIN ANASTOMOSIS, NEITHER INSTRUMENT FUNCTIONED AS INTENDED, AS THE USER WAS UNABLE TO CONNECT THEM TO THE DISPOSABLE COUPLER COMPONENTS. THE USER REMARKED THAT THERE WAS "SOMETHING WRONG WITH THE INTERNAL SPRING MECHANISM", AND THEY COULD VISUALLY OBSERVE THAT SOMETHING WAS OBSTRUCTING IT. MULTIPLE DISPOSABLE COMPONENTS WERE ATTEMPTED WITHOUT SUCCESS. AN OLDER COUPLER INSTRUMENT (ANASTOMOTIC INSTRUMENT) WAS SUBSEQUENTLY USED BUT DEMONSTRATED SIGNIFICANT RESISTANCE. ALTHOUGH AN ANASTOMOSIS WAS ACHIEVED, AN ANASTOMOTIC LEAK WAS DETECTED, REQUIRING A NEW ANASTOMOSIS. DUE TO VESSEL SHORTENING, ADDITIONAL SURGICAL INTERVENTION WAS REQUIRED. PART OF THE RIB HAD TO BE RESECTED, DURING WHICH A CUT OCCURRED AND SIGNIFICANT HEMORRHAGE FROM THE INTERNAL MAMMARY ARTERY HAPPENED. THE SURGEON CLAMPED THE "BLEEDING" PREVENTING ANY MAJOR BLOOD LOSS. DURING SUCH COMP

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 24947595 ↗