Z-1247-2021Class II

Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375

Name: Z-1247-2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Creator: Medtronic Vascular
Published: 2021-01-15
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-01-15 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular began a recall of Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 on 2021-01-15. FDA classified it as Class II and gives the reason as "Sterility may be compromised due to an unsealed pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1247-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-15
Posted: 2021-03-11
Terminated: 2023-06-15
Recalling firm: Medtronic, Inc.
Product: Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375
Product code: DQY Catheter, Percutaneous
Reason for recall: Sterility may be compromised due to an unsealed pouch
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 in commerce: 10 Units
Distribution: Nationwide
Product codes and lots: Lot Code: 220772561, 220772562

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1245-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1246-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1247-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-11
Z-1248-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-11

Product code DQY

K021256Class IIZ3 Guide CatheterMedtronic Vascular / cleared 2002-05-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)