Medtronic Vascular Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35
Brand
Medtronic Vascular
Lot Codes / Batch Numbers
Lot Code: 220712186
Products Sold
Lot Code: 220712186
Medtronic Vascular is recalling Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 due to Sterility may be compromised due to an unsealed pouch. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Sterility may be compromised due to an unsealed pouch
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026