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U.S. Department of Health and Human Services

Class 3 Device Recall AGA AMPLATZER Vascular Plug

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 Class 3 Device Recall AGA AMPLATZER Vascular Plugsee related information
Date Initiated by FirmSeptember 01, 2005
Date PostedNovember 05, 2005
Recall Status1 Terminated 3 on November 13, 2006
Recall NumberZ-0127-06
Recall Event ID 33323
510(K)NumberK031810 
Product Classification Device, Vascular, For Promoting Embolization - Product Code KRD
ProductAMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
Code Information The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
FEI Number 3005334138
Recalling Firm/
Manufacturer		 AGA Medical Corporation
682 Mendelssohn Ave N
Golden Valley MN 55427-4306
Manufacturer Reason
for Recall		Five lots of AMPLATZER Vascular Plugs were sterilized in a load that was not validated for the AMPLATZER Vascular Plug. However, only three of those five lots were distributed.
FDA Determined
Cause 2		Other
ActionUrgent Recall letters, dated 09/01/05, were sent to affected customers via email, facsimile and with follow-up delivery via USPS. OUS customers were notified via Federal Express. The letter described the situation, the lots being recalled and included a response form that was to be faxed back to AGA Medical.
Quantity in Commerce81
DistributionOUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = KRD
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