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GEM FLOW COUPLER

SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM2752 FC · UDI-DI 00844735005998

DPW MVR Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

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.

Recalls

Date	Firm	Reason
2026-03-04	Koven Technology, Inc.	Product labeling includes a fetal indication for use that is not cleared under its 510(k).
2025-09-26	Medistim Asa	Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer S
2025-08-07	Flosonics Medical (R/A 1929803 ONTARIO CORP.)	Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
2023-06-19	Baxter Healthcare Corporation	An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B
2018-06-19	Vascular Technology, Inc.	Device maybe mislabeled as a 20 MHz Doppler transceiver instead of an 8 MHz Doppler transceiver
2017-04-25	Medistim Asa	A system component overheated causing melting of the connector and emission of smoke through the systems loudspeaker opening.
2016-04-21	Baxter Healthcare Corp.	Instructions for use booklet may puncture the outer Tyvek lid.
2016-04-21	Baxter Healthcare Corp.	Instructions for use booklet may puncture the outer Tyvek lid.
2016-04-21	Baxter Healthcare Corp.	Instructions for use booklet may puncture the outer Tyvek lid.
2016-04-21	Baxter Healthcare Corp.	Instructions for use booklet may puncture the outer Tyvek lid.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.