FDA Medical Device Recalls (openFDA)
Medtronic Vascular: Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
- Recall number
- Z-1247-2021
- Recalling firm
- Medtronic Vascular
- Product
- Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
- Status
- Terminated
- Initiated
- 2021-01-15
- Posted
- not on file
- Terminated
- 2023-06-15
- Reason
- Sterility may be compromised due to an unsealed pouch
- Root cause
- Process control
- Action
- 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.
- Quantity
- 10 Units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot Code: 220772561, 220772562
- 510(k) numbers
- ["K021256"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 1220452
- Firm city
- Danvers
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28