GEM FLOW COUPLER GEM2752 FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844735005998), received between Oct 15, 2020 and Aug 6, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RING OF A 2.0MM FLOWCOUPLER WAS NOT ALIGNED, WHICH PREVENTED THE USE OF THE DEVICE DURING SURGERY. 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 22731153 ↗
• MalfunctionAug 6, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE RING OF A 2.0MM COUPLER WAS NOT ALIGNED DURING USE IN 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 22727701 ↗
• MalfunctionOct 15, 2020Misconnection; Misconnection

  IT WAS REPORTED THAT DURING ANASTOMOSIS WITH A FLOW COUPLER, THERE WAS A RING DISLODGEMENT AND THE RINGS WERE FOUND NOT TO BE ALIGNED. IT WAS REPORTED THAT AFTER INTEGRATING THE PROBE TO THE APPLICATOR, IT BECAME DETACHED. THIS HAPPENED BEFORE PATIENT USE. A SECOND COUPLER WAS USED TO PERFORM THE ANASTOMOSIS. 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 10687104 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING ANASTOMOSIS USING TWO COUPLER UNITS, THERE WAS A RING DISLODGEMENT AND THE RINGS WERE FOUND NOT TO BE ALIGNED. AFTER INTEGRATING THE FIRST PROBE TO THE APPLICATOR, IT BECAME DETACHED. THIS HAPPENED BEFORE PATIENT USE. A SECOND PROBE WAS SUCCESSFULLY ATTACHED AND THE VESSEL ENDS WERE PULLED THROUGH THE COUPLER AND BOTH RINGS WERE JOINED, HOWEVER, AFTER COMPLETING THE ANASTOMOSIS, THE SURGEON REALIZED IT WAS "NOT WELL MADE" AND THERE WAS A MASSIVE LEAK POSSIBLY DUE TO THE ¿RINGS WERE NOT WELL ADAPTED¿. IT WAS REPORTED THAT THE SURGEON "CUT THE VESSEL" AND PERFORMED A MANUAL ANASTOMOSIS. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 10687079 ↗