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Terminated

Medtronic Adjustable Valve, 6248VAL, Sterilized using irradiation. Medtronic, Inc. Minneapolis, MN 55432, USA. The Medtronic model 6248VAL adjustable valve is an accessory designed for use with Medtronic delivery systems to reduce blood loss during percutaneous catheter procedures. It consists of an adjustable valve and flush port.

FDA Recall Z-2471-2008 · Posted 2008-09-30

Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeDTL
Date Initiated2008-08-27
Date Terminated2011-05-07
Product Quantity35,193 total

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0524596248VAL ADJUSTABLE VALVEMedtronic Vascular · 2006-01-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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