GEM Microvascular Anastomotic COUPLER GEM2755Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00844735002706), received between Aug 21, 2020 and Jul 29, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionFeb 6, 2026Difficult to Open or Close; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A 3.5MM FLOW COUPLER DID NOT CLOSE PROPERLY AND WAS MISALIGNED. THE ISSUE OCCURRED DURING AN INTRA-OPERATION STEP. 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 24284503 ↗
• MalfunctionDec 31, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RINGS OF A 3.5MM COUPLER REPEATEDLY DISLODGED FROM THE INSTRUMENT PRIOR TO PERFORMING THE ANASTOMOSIS. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936428 ↗
• MalfunctionOct 31, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PINS OF A 3.5MM COUPLER WERE MAL-ALIGNED, RESULTING IN FAILED ANASTOMOSIS. THIS OCCURRED DURING PATIENT USE. THE COUPLER 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 23438126 ↗
• MalfunctionJul 22, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE RINGS OF TWO (2) 4.0MM COUPLERS FELL OUT OF THE WINGED ASSEMBLY. THIS WAS OBSERVED DURING AN 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 22571375 ↗
• MalfunctionJun 4, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT A 3.5MM COUPLER WAS NOT ALIGNED DURING USE IN AN INTRA-OP PROCEDURE. THE ISSUE WAS FURTHER DESCRIBED AS, "THE SURGEON DEEMED IT BROKEN". A NEW COUPLER 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 22143396 ↗
• MalfunctionNov 12, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE STEEL NEEDLE (PIN) OF A 3.5MM COUPLER WAS "CROOKED". THIS WAS NOTICED AFTER THE ANASTOMOSIS RING WAS INSTALLED AND VISUALLY INSPECTED UNDER THE MICROSCOPE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664801 ↗
• MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 3.5MM COUPLER FELL OFF IMMEDIATELY AFTER THE REMOVAL OF THE WHITE CAP. THIS OCCURRED AFTER THE COUPLER WAS ATTACHED TO THE ANASTOMOTIC INSTRUMENT; HOWEVER, THE COUPLER WAS NOT INSERTED. 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 20409704 ↗
• MalfunctionAug 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A 3.5MM COUPLER PREMATURELY EJECTED FROM THE BLACK BUTTERFLY ASSEMBLY. A NEW 3.5MM COUPLER WAS LOADED ONTO THE ANASTOMOTIC COUPLER. THE PHYSICIAN INSERTED THE VESSELS END INTO THE COUPLER RINGS AND EVERTED THE EDGES OVER THE PINS. AS THE PHYSICIAN WAS APPROXIMATING THE RINGS BY TURNING THE COUPLER INSTRUMENT KNOB, ONE OF THE RINGS PREMATURELY FELL/POPPED OUT OF THE BUTTERFLY ASSEMBLY. THE RINGS WERE REMOVED BY CUTTING THE VESSEL ENDS. THE PHYSICIAN STARTED OVER WITH A NEW SET. 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 20080636 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A 3.5MM COUPLER PREMATURELY EJECTED FROM THE BLACK BUTTERFLY ASSEMBLY. A NEW 3.5MM COUPLER WAS LOADED ONTO THE ANASTOMOTIC COUPLER. THE PHYSICIAN INSERTED THE VESSEL SEND INTO THE COUPLER RINGS, EVERTED THE EDGES OVER THE PINS. AS THE PHYSICIAN WAS APPROXIMATING THE RINGS BY TURNING THE COUPLER INSTRUMENT KNOB, ONE OF THE RINGS PREMATURELY FELL/POPPED OUT OF THE BUTTERFLY ASSEMBLY. TO COMPLETE THE PROCEDURE THE PHYSICIAN CHOSE TO SUTURE THE VEIN 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 20072657 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE RING OF A 3.5MM COUPLER PREMATURELY EJECTED (FELL OFF) FROM THE BLACK BUTTERFLY ASSEMBLY. THIS WAS OBSERVED AFTER THE COUPLER WAS LOADED ONTO THE ANASTOMOTIC DEVICE AND LAID ON THE STAND. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064863 ↗
• MalfunctionAug 21, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A 3.5MM COUPLER HAD A CURVED NEEDLE ON ONE SIDE AND THREE CURVED NEEDLES ON ONE SIDE. THIS ISSUE WAS IDENTIFIED DURING SETUP AND PREPARATION PRIOR TO PATIENT USE. A NEW PRODUCT OF THE SAME MODEL WAS USED WITH NO ISSUES. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10438004 ↗