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Recall Observatory FDA recall evidence

Device product

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Z-0205-2015

October 13, 2014

Class II

Product summary

Firm
Medtronic Vascular
Event
Event 69488
Status
Terminated
Classification
Class II
Quantity
11 devices
Official record key
device-enforcement:Z-0205-2015

Official wording

Reason: 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

Code information: Lot Number: 0007244836 MODEL: LA6JR40K

Distribution pattern: US Distribution including the states of NC, IA, IL and KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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