Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

FDA device recall Z-0205-2015 · posted 2014-11-13 · Terminated

Recall details

Recalling firm

Medtronic Vascular

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

Action taken

Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action. 1. Identify and quarantine all listed, unused product in your inventory. 2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can assist you in the return of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.

Root cause

Process control

Status

Terminated

Product code

DQY

Quantity affected

11 devices

Distribution

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

Date initiated

2014-10-13

Date posted

2014-11-13

Date terminated

2015-02-18

Location

Danvers, MA

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