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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLATZER PFO Occluder

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 Class 2 Device Recall AMPLATZER PFO Occludersee related information
Date Initiated by FirmJune 01, 2006
Date PostedOctober 20, 2006
Recall Status1 Terminated 3 on April 01, 2007
Recall NumberZ-0053-2007
Recall Event ID 35814
Product Classification Occluder - Product Code MLV
ProductAMPLATZER PFO Occluder. Order No. 9-PFO-025. Device is not PMA approved in the US. 25mm Sterile EO. The AMPLATZER PFO Occluder is a self-expandable, double disc device made from a Nitinol wire mesh. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA.
Code Information Lot number M06B01-58, serial numbers 190495 - 190512
FEI Number 3005334138
Recalling Firm/
Manufacturer		 AGA Medical Corporation
682 Mendelssohn Ave N
Golden Valley MN 55427-4306
Manufacturer Reason
for Recall		AMPLATZER PFO Occluders were mislabeled with incorrect device sizes. The lot M06B01-58 contains 18mm PFO Occluders but is labeled as containing 25mm devices. Lot M06B01-52 contains 25mm PFO Occluders but is labeled as containing 18mm devices. The affected product was not distributed within the United States and does not affect U.S. consignees.
FDA Determined
Cause 2		Other
ActionConsignees were notified of the recall via fax and mail. Consignees were instructed to cease distribution and use of the devices. Returned devices will be replaced.
Quantity in Commerce18
DistributionForeign Distribution ONLY-Product was distributed in Italy, Switzerland, Germany and the Slovak Republic.
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.
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