Hansen Medical Inc recalls Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan Syst…

Recall date

March 25, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1564-2016

FDA classification

Class II

Brand / firm

Hansen Medical Inc

Sold / distributed

Nationwide Distribution to OH, TX. FL, CA and GA.

Why it was recalled

Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.