Z-2473-2008

Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland...

Name: Z-2473-2008 Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland...
Creator: Medtronic Inc. Cardiac Rhythm Managment
Published: 2008-08-27
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2008-08-27 / Terminated / root cause: manufacturing process

FDA source

Medtronic Inc. Cardiac Rhythm Managment began a recall of Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland... on 2008-08-27. The reason FDA records is "Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be...". 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-2473-2008
Status: Terminated
Initiated: 2008-08-27
Posted: 2008-09-30
Terminated: 2011-05-07
Recalling firm: Medtronic, Inc.
Product: Medtronic Attain ACCESS 6218A, Left-heart delivery system. Sterilized. Manufactured in: Medtronic Ireland, Parkmore Business Park West, Galway, Ireland. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432 USA. The Medtronic Attain Access Model 6218A Left-heart delivery system is designed to facilitate lead implantation in the left heart, via the coronary sinus. The Left-heart delivery system features one guide wire to facilitate venous access, an adjustable valve to reduce blood loss during the implant procedure, two guide catheters for passing venogram balloon catheters and appropriate leads, a guide catheter dilator to facilitate guide catheter passage, guide catheter slitters for removing guide catheters, and a guide wire clip to help contain the guide wire in the sterile field.
Product code: DQY Catheter, Percutaneous
Reason for recall: Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An Urgent Device Recall letter, dated August 28, 2008, was sent to affected consignees. The letter describes the issue, identifies affected product, and requests that affected product be removed from inventory and returned to Medtronic. Medtronic representatives with assist in returning unused valves and kits and provide replacements. Contact Medtronic at 1-763-526-0000 for assistance.
Quantity in commerce: 35,193 total
Distribution: Worldwide Distribution --- including USA and except states OR, RI, and SD. Puerto Rico and Washington D.C. , and countries of Algeria , Argentina , Australia , Austria , Belgium , Bosnia And Herzegovina , Canada , Chile , Croatia , Czech Republic , Denmark , Egypt , Finland , France , Georgia , Germany , Greece , Guadeloupe , Hong Kong , Hungary , India , Ireland , Israel , Italy , Japan , Jordan , Kazakhstan , Kuwait , Lithuania , Malta , Martinique , Morocco , Netherlands , Norway , Pakistan , Poland , Portugal , Puerto Rico ,Qatar , Reunion , Romania , Saudi Arabia , Slovakia , Slovenia , South Africa , Spain , Sri Lanka , Sweden , Switzerland , Syrian Arab Republic , Tunisia , Turkey , UK , Ukraine , United Arab Emirates , Uruguay , and Venezuela.
Product codes and lots: Lot numbers: 0000551738, 0000551739, 0000551741, 0000565825, 0000565832, 0000572089, 0000594851, 0000594862, 0000602543, 0000616817. 0000618326, 0000618336, 0000623484, 0000623485, 0000623486, 0000634811, 0000639818, 0000642709, 0000642711, 0000659204, 0000700682, 0000737899, 0000741822, 0000741823, 0000753219

Product code DQY

K021589Class IIAttain Access 6218A Left-Heart Delivery System, Model 6218Medtronic Vascular / cleared 2002-05-30

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)