GEM FLOW COUPLER GEM2753 FCRecalls & reported problems
Synovis Micro Companies Alliance, Inc · The FlowCOUPLER System consists of a FlowCOUPLER Device and a FlowCOUPLER Monitor. The FlowCOUPLER Device includes a 20MHz ultrasonic Doppler transducer (probe) attached to one of the FlowCOUPLER rings, and an external lead. The FlowCOUPLER rings are made of high density polyethylene and surgical grade stainless steel pins. A protective cover and jaw assembly protect the rings and probe which allow for easy loading onto the Anastomotic Instrument. Both the protective cover and jaw assembly are disposable. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00844735006001), received between Jun 15, 2024 and Jun 3, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED THAT A 2.5MM FLOWCOUPLER SPRUNG OPEN AND FAILED TO LOCK INTO PLACE WHEN ATTEMPTING TO CLOSE THE IMPLANTABLE DEVICE. THIS WAS OBSERVED 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 22133169 ↗MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT A RING OF A 2.5MM FLOW COUPLER FELL OUT. THIS WAS OBSERVED DURING VENOUS ANASTOMOSIS, AFTER A VEIN WAS INSTALLED INTO ONE SIDE OF THE COUPLER; THE OTHER SIDE OF THE COUPLER FELL OFF THE APPLICATOR. THERE WAS NO REPORT OF PATIENT INJURY; HOWEVER, A NEW COUPLER WAS USED TO CONTINUE THE PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679433 ↗MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RINGS OF TWO (2) 2.5MM FLOWCOUPLERS PREMATURELY EJECTED (FELL OFF) FROM THE CLIP. THIS WAS OBSERVED BEFORE CLOSING THE APPLICATOR, WHEN THE RING WAS PLACED IN THE VEIN. DURING THE PROCEDURE, THE RING FELL OUT OF THE CLIP WHILE SECURING THE VEIN. THE SURGEON WAS UNABLE TO LOCATE THE RING WITHIN THE CLIP. AS A RESULT, A SECOND IMPLANT WAS UTILIZED. THE SAME CHECKS WERE PERFORMED, AND PROCEEDED WITH EXTRA CARE; HOWEVER, THE SAME ISSUE OCCURRED AGAIN. 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 20157878 ↗MalfunctionJun 15, 2024Break; Break
IT WAS REPORTED THAT A 2.5MM FLOW COUPLER WAS BROKEN (NOT FURTHER SPECIFIED). THIS WAS IDENTIFIED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19544379 ↗
Other FLOWMETER, BLOOD, CARDIOVASCULAR devices
- GEM FLOW COUPLER MONITOR GEM1020M-2Synovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR2 recalls0 reports
- Dual Adhesive Strap FP120-FOT01-0051929803 Ontario Corp · Flowmeter, Blood, Cardiovascular1 recall0 reports
- BiDop 3Koven Technology, Inc. · Flowmeter, Blood, Cardiovascular1 recall0 reports
- GEM FLOW COUPLER GEM2752 FCSynovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR4 reports
- Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box 138660Vascular Technology, Incorporated · FLOWMETER, BLOOD, CARDIOVASCULAR1 report
- GEM FLOW COUPLER GEM2755 FCSynovis Micro Companies Alliance, Inc · FLOWMETER, BLOOD, CARDIOVASCULAR1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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