GEM Microvascular Anastomotic COUPLERRecalls & reported problems across all models

We found 13 models of GEM Microvascular Anastomotic COUPLER by Synovis Micro Companies Alliance, Inc in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Jan 2, 2020 and Sep 15, 2026 — classified as 7 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (32 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GEM Microvascular Anastomotic COUPLER problems

GEM Microvascular Anastomotic COUPLER models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GEM Microvascular Anastomotic COUPLER GEM2753

  Device,anastomotic,microvascular
  44 reports
• GEM Microvascular Anastomotic COUPLER GEM2754

  Device,anastomotic,microvascular
  28 reports
• GEM Microvascular Anastomotic COUPLER GEM2751

  Device,anastomotic,microvascular
  13 reports
• GEM Microvascular Anastomotic COUPLER GEM2755

  Device,anastomotic,microvascular
  13 reports
• GEM Microvascular Anastomotic COUPLER GEM2752

  Device,anastomotic,microvascular
  10 reports
• GEM Microvascular Anastomotic COUPLER GEM2753 I

  Device,anastomotic,microvascular
  6 reports
• GEM Microvascular Anastomotic COUPLER GEM2754 I

  Device,anastomotic,microvascular
  5 reports
• GEM Microvascular Anastomotic COUPLER GEM2750

  Device,anastomotic,microvascular
  3 reports
• GEM Microvascular Anastomotic COUPLER GEM2751 I

  Device,anastomotic,microvascular
  2 reports
• GEM Microvascular Anastomotic COUPLER GEM2752 I

  Device,anastomotic,microvascular
  2 reports
• GEM Microvascular Anastomotic COUPLER GEM2756

  Device,anastomotic,microvascular
  2 reports
• GEM Microvascular Anastomotic COUPLER GEM2750 I

  Device,anastomotic,microvascular
  1 report
• GEM Microvascular Anastomotic COUPLER GEM2755 I

  Device,anastomotic,microvascular
  1 report

Recent GEM Microvascular Anastomotic COUPLER adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573298 ↗
• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572840 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component

  It was reported that the rings of two (2) GEM COUPLERs,3.5MM were detached. This occurred during the placement of the coupler device on the anastomotic instrument. The device was replaced 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 50075717 ↗
• MalfunctionJul 29, 2026Material Twisted/Bent

  It was reported that the bristles were bent in a GEM COUPLERs,3.5MM. This was observed during the intra op 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 50075716 ↗
• InjuryJul 27, 2026Detachment of Device or Device Component

  It was reported that the ring of a GEM COUPLER,2.5MM had opened. This occurred after a bilateral deep inferior epigastric perforator (DIEP) breast reconstruction procedure. Postoperative monitoring identified right breast swelling and lack of flap flow. The patient was returned to the operating room for re-examination and confirmation of flap failure. During the re-examination, the right sided coupler was observed to be open. The physician reported that the DIEP vein had separated from the internal mammary vein (IMV) at the coupler site; however, the cause of the separation could not be determined. Attempts to recover the flap were unsuccessful. The reporting surgeon stated that the observed irreparable damage to the internal mammary vein suggested an avulsion mechanism rather than an intrinsic defect in the coupler itself. No additional information is available.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50024851 ↗
• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50001122 ↗
• MalfunctionJul 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904478 ↗
• 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 ↗
• MalfunctionJun 19, 2026Failure to Align

  DURING EVALUATION OF A PHOTO SAMPLE, IT WAS OBSERVED THAT A 2.5MM COUPLER HAD MISALIGNED RINGS. THE RINGS APPEARED TO BE SUCCESSFULLY APPROXIMATED AND JOINED, ALTHOUGH THEY APPEARED TO BE SLIGHTLY MISALIGNED. 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 25565388 ↗
• 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 ↗
• 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 2.0MM 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 24875289 ↗
• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT A 2.5MM 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 24875204 ↗
• 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 24875093 ↗