Recalls / —

—#185722

Product

Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35

FDA product code

DQY — Catheter, Percutaneous

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K021256

Affected lot / code info

Lot Code: 220712186

Why it was recalled

Sterility may be compromised due to an unsealed pouch

Root cause (FDA determination)

Process control

Action the firm took

Medtronic issued 15-Jan-2021 Medical Device Correction letter via UPS 2-day to consignees stating reason for recall, health risk, and action to take: Medtronic records indicate that your facility has received one or more of the affected Launcher Guide Catheters. As a result, Medtronic requests that you immediately take the following actions: "Identify and quarantine all unused affected 6F Launcher Guide Catheters as listed in the table above. "Return/Exchange all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at1-800-716-6700 to initiate a product return/exchange. Your local Medtronic Representative can assist you in thereturn of this product. "Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Questions regarding this communication, please contact your Medtronic Field Representative.

Recalling firm

Firm

Medtronic Vascular

Address

35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565

Distribution

Distribution pattern

Nationwide

Timeline

Recall initiated

2021-01-15

Terminated

2023-06-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #185722. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.