GEM FLOW COUPLER GEM2754 FCRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00844735006018), received between Jun 25, 2024 and Oct 17, 2025 — classified as 6 malfunctions.

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

• MalfunctionOct 17, 2025Misconnection; Misconnection

  IT WAS REPORTED THAT A 3.0 MM FLOWCOUPLER RING PINS DID NOT PROPERLY LINE UP TO INSERT PROPERLY IN THE OPPOSING COUPLER RING. THIS WAS OBSERVED DURING A PERIPHERAL FREE FLAP. 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 23327934 ↗
• MalfunctionOct 1, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A 3.0MM FLOW COUPLER WAS NOT CLOSING ALL THE WAY EVEN WHEN THE DEVICE WAS CLOSED ALL THE WAY. THE SPIKES COULD BE SEEN JUST STARTING TO PENETRATE THE OTHER SIDE; HOWEVER, IT WAS NOT NEAR TO WHERE IT NORMALLY SHOULD BE. THE ISSUE OCCURRED DURING AN INTRA-OPERATION STEP. WHEN SQUEEZING THE FLOW COUPLER, THE DEVICE WOULD NOT COMPLETELY CLOSE. 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 23193419 ↗
• MalfunctionMar 6, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ONE OF THE PRONGS ON A FLOWCOUPLER SYSTEM WAS BENT. THIS WAS DISCOVERED 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 21536695 ↗
• MalfunctionFeb 13, 2025Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE RINGS OF A 3.0MM FLOW COUPLER WERE MISALIGNED DURING A VENOUS ANASTOMOSIS PROCEDURE ON A PATIENT. THE RINGS DID CLOSE; HOWEVER, THE "PRONGS DID NOT MATCH UP PROPERLY FROM ONE SIDE OF THE JAW ASSEMBLY TO THE OTHER RECIPROCAL SIDE RECEIVER". THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, THE DEVICE WAS EXPLANTED AND REPLACED TO REDO THE ANASTOMOSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21377324 ↗
• MalfunctionSep 27, 2024Disconnection; Incomplete or Inadequate Connection; Disconnection; Incomplete or Inadequate Connection

  IT WAS REPORTED A 3.0MM FLOWCOUPLER FAILED TO HOLD THE VEIN SECURELY, REPEATEDLY SLIPPING OFF THE PRONGS. IT WAS ALSO REPORTED THAT UPON ATTEMPTING TO CLOSE THE COUPLER, THE PRONGS DID NOT ALIGN PROPERLY, PREVENTING THE COUPLER FROM CLOSING. TO RESOLVE THIS ISSUE, THE SURGEON QUICKLY OPENED ANOTHER COUPLER AND DID NOT EXPERIENCE ANY DIFFICULTIES OR ISSUES. 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 20322180 ↗
• MalfunctionJun 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A FLOWCOUPLER PROBE CABLE WAS NOT CONNECTED AND THE RING DISCONNECTED DURING CONDITIONING. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP DURING AN UNSPECIFIED SURGERY. 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 19607348 ↗