PlainRecalls
FDA Devices Moderate Class II Terminated

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Reported: November 19, 2014 Initiated: October 13, 2014 #Z-0205-2015

Product Description

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Reason for Recall

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

Details

Recalling Firm
Medtronic Vascular
Units Affected
11 devices
Distribution
US Distribution including the states of NC, IA, IL and KS.
Location
Danvers, MA

Frequently Asked Questions

What product was recalled?
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K. Recalled by Medtronic Vascular. Units affected: 11 devices.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2014. Severity: Moderate. Recall number: Z-0205-2015.