GEM FLOW COUPLER GEM2755 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00844735006025), received between Jul 2, 2025 and Jul 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Twisted/Bent” (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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 2, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PIN ON THE 3.5MM FLOW COUPLER WAS MOVING AND "LOOSE". THIS WAS OBSERVED DURING AN INTRA-OP PROCEDURE, WHEN TRYING TO EVERT THE VESSEL ONTO THE PIN. 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 22390969 ↗
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
- GEM FLOW COUPLER GEM2753 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
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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