GEM Microvascular Anastomotic COUPLER GEM2751Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844735002621), received between Jun 9, 2020 and Jul 27, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50001122 ↗
• MalfunctionMay 28, 2026Fitting Problem

  IT WAS REPORTED THAT THE RING OF THREE (3) 1.5MM GEM COUPLERS DID NOT FIT. THIS OCCURRED DURING USE IN THE OPERATING ROOM. 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 25317324 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 1.5MM COUPLER WAS LOOSE AND CAME OFF. THIS WAS OBSERVED DURING PREPARATION BEFORE A SURGICAL PROCEDURE. THE DOCTOR REPLACED THE PRODUCT TO CONTINUE PREPARATION FOR THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24719752 ↗
• MalfunctionMar 9, 2026Misconnection

  IT WAS REPORTED THAT THE RINGS OF A 1.5MM COUPLER DID NOT MATCH. THIS OCCURRED DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT. THE PROCESS WAS COMPLETED WITH A NEW DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543423 ↗
• MalfunctionJan 21, 2026Disconnection

  IT WAS REPORTED THAT DURING THE USE OF A MICROVASCULAR ANASTOMOTIC COUPLER, THE RING CAME OFF AND THE DEVICE COULD NOT BE USED. THIS EVENT OCCURRED DURING INCOMING INSPECTION OF THE PREOPERATIVE STAGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130729 ↗
• MalfunctionAug 26, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE ANASTOMOTIC INSTRUMENT OF A 1.5MM COUPLER WOULD NOT CLOSE. THE EVENT OCCURRED DURING AN ANTEROLATERAL FEMORAL FREE FLAP REPAIR AFTER ¿HANGING THE PINS¿. CLOSURE WAS SUCCESSFULLY COMPLETED BY MANUAL SUTURING. 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 20072847 ↗
• MalfunctionJun 1, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 3.0MM COUPLER HAD A BENT PIN. THIS WAS IDENTIFIED DURING AN INTRAOPERATIVE PROCEDURE. TO RESOLVE THE EVENT, A NEW COUPLER WAS USED. 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 17038925 ↗
• MalfunctionMay 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 1.5MM COUPLER FELL OFF. THIS WAS IDENTIFIED 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 17030497 ↗
• MalfunctionMar 27, 2023Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT A 1.5MM COUPLER WAS NOT CLOSING PROPERLY; THE RING WAS NOT ABLE TO FULLY ATTACH. THIS WAS DISCOVERED DURING PATIENT 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 16623547 ↗
• MalfunctionMar 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PINS OF A 1.5MM COUPLER WERE BENT. THIS WAS IDENTIFIED BEFORE 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 16618716 ↗
• MalfunctionFeb 18, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE RINGS OF 1.5MM COUPLER WOULD NOT FULLY ATTACH (CLOSE). THIS WAS OBSERVE DURING PATIENT 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 13563938 ↗
• MalfunctionJan 7, 2021Loose or Intermittent Connection; Material Twisted/Bent; Loose or Intermittent Connection; Material Twisted/Bent

  IT WAS REPORTED THAT A STEEL NEEDLE OF THE 1.5MM COUPLER WAS BENT ON ONE SIDE OF THE ANASTOMOSIS RING. IT WAS FURTHER REPORTED THAT THE OTHER STEEL NEEDLES WERE LOOSE AND COULD NOT BE USED. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. THE COUPLER WAS REPLACED TO COMPLETE THE SURGERY AND THE PATIENT WAS WELL. 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 11135240 ↗
• MalfunctionJun 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE PIN OF A 1.5MM COUPLER WAS OBSERVED BENT. THIS ISSUES WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10136504 ↗