GEM Microvascular Anastomotic COUPLER GEM2753 IRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844735002652), received between Oct 22, 2020 and Apr 14, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO (2) 2.5MMCOUPLERS HAD BENT PINS. THIS WAS OBSERVED WHEN TAKING THE COUPLERS OUT OF THE PACKAGING. TO RESOLVE THE EVENT, A NEW COUPLER WAS USED TO CONTINUE PREPARATION. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23363468 ↗
• MalfunctionAug 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A 2.5MM COUPLER POPPED OPEN AFTER CLOSURE AND CLAMPING. THE EVENT WAS FURTHER DESCRIBED AS "ANASTOMOSIS STRENGTH WAS NOT STRONG ENOUGH". 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 20071148 ↗
• MalfunctionJun 10, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE RINGS FELL OUT OF THE WING JAW ASSEMBLY OF A 2.5MM COUPLER. THIS WAS OBSERVED AFTER THE PRODUCT PACKAGE WAS OPENED, PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19504510 ↗
• MalfunctionMay 21, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THE RING OF A 1.5MM COUPLER WAS NOT ABLE TO FULLY ATTACH AND FAILED TO COMPLETE ANASTOMOSIS. THIS ISSUE 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 14465756 ↗
• MalfunctionOct 22, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE RING OF A 2.5MM COUPLER DEVICE CAME OUT OF THE CARTRIDGE. THIS ISSUE WAS IDENTIFIED 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 Consequences Or Impact To Patient

  MAUDE report 10722104 ↗