GEM Microvascular Anastomotic COUPLER GEM2754Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00844735002683), received between Aug 25, 2020 and Sep 15, 2026 — classified as 2 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (8 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Misconnection; Failure to Disconnect

  It was reported that the rings of two (2) 3.0 mm Couplers failed to release completely from the jaws. Additionally, in one coupler, the pins failed to align, resulting in an anastomotic failure. This occurred during patient use. The issue was ultimately resolved by gently dislodging the rings from the jaws using a hemostat, allowing the procedure to be completed successfully. 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 50774545 ↗
• MalfunctionJul 3, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A GEM COUPLER,3.0MM WAS DETACHED WHEN ATTEMPTING TO CONNECT A BLOOD VESSEL. THIS OCCURRED DURING BREAST RECONSTRUCTION SURGERY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. 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 25706943 ↗
• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT A 3MM COUPLER 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 24875291 ↗
• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM COUPLER 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 24875040 ↗
• 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 24875036 ↗
• MalfunctionMar 19, 2026

  COUPLER WAS DEFECTIVE AND WOULD NOT FIT INTO COUPLER INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638937 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT A 3.0MM COUPLER FELL APART AND WAS UNUSABLE. THIS WAS OBSERVED WHEN THE DEVICE WAS OPENED TO THE STERILE FIELD. A NEW DEVICE WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470710 ↗
• MalfunctionJan 30, 2026Disconnection

  DURING EVALUATION OF A RETURNED 3.0MM COUPLER, LOOSE RINGS WITHIN THE INNER TRAY WERE OBSERVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24225356 ↗
• MalfunctionOct 20, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PINS OF A MICROVASCULAR ANASTOMOTIC COUPLER DEVICE WERE NOT ENGAGING THE OPPOSING HOLES WHEN CLOSING. THIS ISSUE OCCURRED DURING USE OF THE DEVICE 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 23342994 ↗
• MalfunctionSep 18, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RINGS OF TWO (2) 3.0MM COUPLERS FELL OUT OF THE WING WITHOUT ANY SIGNIFICANT PRESSURE. THIS WAS OBSERVED WHILE INSERTING THE COUPLER INTO THE "RIGHT RING" WHILE HOLDING THE DEVICE BY HAND DURING AN INTRA-OPERATION STEP. ANOTHER ATTEMPT WAS MADE TO INSERT FROM THE TIP; HOWEVER, WAS LOOSE AND FELL OUT AGAIN. THE ISSUE WAS RESOLVED BY CHANGING THE SIZE TO A 2.5MM COUPLER. 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 23089691 ↗
• MalfunctionJun 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RINGS OF AN UNSPECIFIED COUPLER DISLODGED FROM THE INSTRUMENT. THIS OCCURRED BEFORE COMPLETION OF 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 22127655 ↗
• MalfunctionMay 22, 2025Material Twisted/Bent; Incomplete or Inadequate Connection; Material Twisted/Bent; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE PINS OF A 3.0MM COUPLER WERE CROOKED AND COULD NOT BE FULLY ATTACHED. THIS WAS OBSERVED DURING PRE-OPERATION SET UP. 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 22074941 ↗
• InjuryMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN INCOMPLETE ANASTOMOSIS OCCURRED ON A 3.0 MM COUPLER WHICH RESULTED IN "LEAKING" AFTER INSERTION. THIS OCCURRED DURING INTRA OPERATION PROCESS STEP. THERE WAS NO REPORT OF 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

  MAUDE report 21953359 ↗
• MalfunctionApr 30, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT A RING OF A 3.0 MM COUPLER "FLEW OUT OF THE APPLICATOR" PRIOR TO 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 21938234 ↗
• MalfunctionMar 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 3.0MM COUPLER FELL OUT OF THE DEVICE. THIS OCCURRED DURING 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 21663010 ↗
• MalfunctionMar 4, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM COUPLER DID NOT CLAMP TIGHTLY ONTO THE VEIN. THIS WAS OBSERVED DURING A FREE FLAP GRAFT PROCEDURE. A NEW COUPLER WAS USED TO CONTINUE THE 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 21519002 ↗
• MalfunctionJan 27, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE "NEEDLE HOLES" OF A 3.0MM COUPLER WERE MISALIGNED RESULTING IN A FAILED ANASTOMOSIS. THIS WAS OBSERVED DURING PRE-OPERATION SET UP. 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 21247990 ↗
• MalfunctionNov 6, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE WING JAWS WOULD NOT CLOSE DURING PATIENT USE OF THREE (03) 3.0MM COUPLERS. THE ANASTOMOTIC INSTRUMENT WAS INSPECTED AND HAD NO OBSERVED MECHANICAL ISSUES. THE COUPLERS WERE REPLACED TO RESOLVE THE EVENT. 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 20626077 ↗
• MalfunctionOct 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 3.0MM MICROVASCULAR ANASTOMOTIC COUPLER DEVICE WAS FAULTY. THE COUPLER WAS NOT SEALING WELL IN THE APPLICATORY AND WAS LOOSE. THIS OCCURRED DURING USE OF THE DEVICE. 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 20546175 ↗
• MalfunctionAug 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PLASTIC RING OF TWO (2) 3.0MM COUPLERS CAME LOOSE FROM THE DEVICE. THE RINGS WHERE THE VEIN ATTACHES CAME LOOSE DURING FREE FLAP PROCEDURE PRIOR TO THE SURGEON READINESS. A THIRD 3.0MM COUPLER WITH A DIFFERENT LOT NUMBER WAS THEN OPENED AND USED WITH NO ISSUE. 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 19960638 ↗
• MalfunctionAug 7, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM COUPLER DID NOT CLOSE PROPERLY; FURTHER DESCRIBED AS "MISFIRE. COUPLER DID NOT MEET". THIS OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19934997 ↗
• MalfunctionApr 25, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM COUPLER WOULD NOT CLOSE. THE ISSUE WAS DISCOVERED DURING PATIENT USE. A NEW COUPLER WAS USED TO RESOLVE THE EVENT. 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 16808284 ↗
• MalfunctionMar 17, 2023Product Quality Problem; Difficult to Open or Close; Product Quality Problem; Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM COUPLER WOULD NOT CLOSE; EACH COUPLER (RING) SEEMED A DIFFERENT SIZE. THIS WAS OBSERVED DURING A SURGICAL PROCEDURE ON A PATIENT. A NEW COUPLER WAS USED TO CONTINUE THE 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 16565961 ↗
• MalfunctionJul 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 3.0MM COUPLER HAD A BROKEN COMPONENT; THE RING PIN WAS CROOKED SO IT WAS NOT ABLE TO BE FULLY ATTACHED. THIS WAS IDENTIFIED DURING A PATIENT PROCEDURE 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 14988281 ↗
• MalfunctionFeb 18, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE RINGS OF A 3.0MM COUPLER WERE ¿A BIT LOOSE¿ AND WERE UNABLE TO FULLY ATTACH. THIS OCCURRED DURING USE. ANOTHER COUPLER WAS USED TO COMPLETE 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 13563999 ↗