—#130755

Product

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

FDA product code: DQY — Catheter, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K021256
Affected lot / code info: Lot Number: 0007244836 MODEL: LA6JR40K

Why it was 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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Vascular
Address: 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

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

Timeline

Recall initiated: 2014-10-13
Posted by FDA: 2014-11-13
Terminated: 2015-02-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #130755. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.