Z-0205-2015Class II

Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K

Name: Z-0205-2015 Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Creator: Medtronic Vascular
Published: 2014-10-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-10-13 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular began a recall of Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K on 2014-10-13. FDA classified it as Class II and gives the reason as "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...". 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-0205-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-13
Posted: 2014-11-13
Terminated: 2015-02-18
Recalling firm: Medtronic, Inc.
Product: Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Product code: DQY Catheter, Percutaneous
Reason for recall: 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 tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected] or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.
Quantity in commerce: 11 devices
Distribution: US Distribution including the states of NC, IA, IL and KS.
Product codes and lots: Lot Number: 0007244836 MODEL: LA6JR40K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0205-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0205-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)