FDA-Device2014-11-19Class II
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Medtronic Vascular
Hazard
Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. Usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the
Sold states
US Distribution including the states of NC, IA, IL and KS.
Affected count
11 devices
Manufactured in
35-37A Cherry Hill Drive, Danvers, MA, United States
Products
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2015Don't want to check this manually?
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