Home › MILLAR INC. › Mikro-Tip Catheter Pulse Transducer

Mikro-Tip Catheter Pulse Transducer

MILLAR INC. · Model SPT-301 · UDI-DI 00868924000236

DXO Prescription

510(k) clearances

2,389

Adverse events (20 deaths)

Recalls

Facilities

Description

Mikro-Tip catheters consist of an ultra-miniature pressure sensor(s) at the distal end of a catheter with an electrical connector(s) at the proximal end. The pressure sensor produces an electrical output signal, which varies in direct proportion to the magnitude of sensed pressure or sound. Mikro-Tip catheters are intended for multiple uses.

Recalls

Date	Firm	Reason
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2021-05-26	Edwards Lifesciences, LLC	There is a potential that the pressure tubing may detach from the blood sampling system
2015-11-13	Edwards Lifesciences, LLC	Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devic
2015-07-31	Edward Lifesciences, Llc	Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the sys

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

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.