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CO2

AVINGER, INC. · Model C100 · UDI-DI 00851354004271

CAN Prescription

510(k) clearances

689

Adverse events (23 deaths)

Recalls

113

Facilities

Description

The CO2 Regulator System is intended to supply low pressure CO2, where small volumes of CO2 are needed, during medical procedures. The device is not intended to be marketed for any specific treatment or medical purpose.The CO2 Cartridge is a component of the Avinger CO2 Regulator System which also includes a CO2 regulator (regulator), male luer lock connector and a female-female luer lock connector (removable). The Avinger CO2 Regulator System allows for the CO2 cartridge to be replaced once the gas from the engaged CO2 cartridge has been spent. Replacement CO2 Cartridges are shipped in packs of five (5).

Recalls

Date	Firm	Reason
2023-01-03	Western/Scott Fetzer Company	Gauge malfunction: Digital gauge displays an incorrect tank pressure - displays pressure higher than actual tank pressure. This may lead to tank running out of oxygen during use wi
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2021-10-16	Western/Scott Fetzer Company	VIPR (Valve Integrated Pressure Regulator) - battery rupture, causing the plastic VIPR shroud to break apart with emission of fumes and smoke
2018-05-08	Dynarex Corporation	The device is equipped with a dial that has an inaccurate flow rate indicator.
2015-10-08	Precision Medical, Inc.	These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter
2015-01-31	Western / Scott Fetzer Company	The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death.
2014-04-07	Western / Scott Fetzer Company	Separation events have occurred, including the VIPR separating from the Aluminum cylinder.
2013-03-08	Linde Gas North America Llc	A number of MEDICYL-e Portable Oxygen Systems may have misapplied valve flow knobs.
2012-11-16	Praxair Inc.	Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact.

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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.