| Class 2 Device Recall Medtronic Attain LDS 6216A, Leftheart delivery system | |
Date Initiated by Firm | August 27, 2008 |
Date Posted | September 30, 2008 |
Recall Status1 |
Terminated 3 on May 07, 2011 |
Recall Number | Z-2472-2008 |
Recall Event ID |
49433 |
510(K)Number | K021587 |
Product Classification |
Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting - Product Code DQY
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Product | Medtronic Attain LDS 6216A, 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 LDS Model 6216A 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 pre-shaped 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. |
Code Information |
Lot numbers: 0000561685, 0000561687, 0000564043, 0000572082, 0000572084,0000572086, 0000572326, 0000578715, 0000584146, 0000584147, 0000584220, 0000594827, 0000594840, 0000594855, 0000611672, 0000611681, 0000618331, 0000618337, 0000623483, 0000623487, 0000626572, 0000626573, 0000636688, 0000639819, 0000639820, 0000642702, 0000648673, 0000648675, 0000658459, 0000658917, 0000662611, 0000662613, 0000666446, 0000675923, 000678213, 0000679453, 0000679473, 0000679474, 0000688351, 0000688352, 0000690991, 0000699022, 0000700460, 0000700467, 0000700647, 0000700648, 0000700649, 0000700650, 0000715602, 0000723321, 0000733095, 0000738118, 0000741796, 0000741799, 0000741806, 0000741817, 0000741820, 0000753218, 0000758162, 0000760125, 0000763744, 0000763746 |
Recalling Firm/ Manufacturer |
Medtronic Inc. Cardiac Rhythm Managment 8200 Coral Sea St Ne Mounds View MN 55112-4391
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For Additional Information Contact | 763-526-0000 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQY
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