GEM Microvascular Anastomotic COUPLER GEM2752Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00844735002645), received between May 18, 2020 and May 9, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (5 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A MICROVASCULAR ANASTOMOTIC COUPLER DEVICE HAD A BENT PIN. IT WAS OBSERVED THAT A METAL PIN WAS BENT WHICH WAS DISCOVERED BY THE PLASTICS COORDINATOR PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994695 ↗
• MalfunctionApr 17, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RING OF A 2.0MM COUPLER FELL OFF. THE COUPLER WAS LOADED INTO THE APPLICATOR CORRECTLY; HOWEVER, WHEN THE GUARD WAS REMOVED ONE OF THE RINGS JUST FELL OFF. THIS OCCURRED 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 21861845 ↗
• MalfunctionApr 4, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 2.0MM COUPLER HAD A BENT PIN; FURTHER DESCRIBED AS "ONE OF THE PRONGS WAS BENT". THIS WAS OBSERVED DURING INSPECTION, BEFORE USE IN A BILATERAL BREAST DIEP FLAP RECONSTRUCTION PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE WITH THE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21774409 ↗
• MalfunctionMay 10, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PINS OF A 2.0MM COUPLER WERE BENT. THIS WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908018 ↗
• MalfunctionMar 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 2.0MM COUPLER HAD MISALIGNED RINGS. THIS WAS DISCOVERED DURING INTRAOPERATIVE PROCEDURE. 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 16621873 ↗
• MalfunctionFeb 18, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE RINGS OF A 2.0MM COUPLER WAS UNABLE TO FULLY ATTACH (CLOSE). THIS ISSUE WAS IDENTIFIED DURING SURGICAL ANASTOMOSIS. 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 13564013 ↗
• MalfunctionSep 23, 2021Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT THE PIN OF A 2.0 MM COUPLER APPEARED BENT AND SUBSEQUENTLY "FELL OUT". THE ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12522954 ↗
• MalfunctionAug 30, 2021Difficult to Open or Close; Material Deformation; Difficult to Open or Close; Material Deformation

  IT WAS REPORTED THAT THE PIN OF 2.0MM COUPLER - 6/BX WAS DEFORMED AND UNABLE TO FULLY CLOSE. THIS WAS OBSERVED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12383527 ↗
• MalfunctionAug 24, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 2.0MM COUPLER DEVICE HAD A STEEL NEEDLE ON ONE SIDE OF THE ANASTOMOTIC RING THAT WAS BENT. THIS ISSUE WAS IDENTIFIED WHEN OPENING THE PACKAGE FOR USE. A NEW COUPLER WAS USED TO COMPLETE PROCEDURE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10445775 ↗
• MalfunctionMay 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF 2.0MM COUPLER DETACHED FROM THE U-PORT. THIS WAS OBSERVED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10066238 ↗