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U.S. Department of Health and Human Services

Class 2 Device Recall AMPLATZER Sizing Balloon II

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 Class 2 Recall
AMPLATZER Sizing Balloon II
see related information
Date Posted September 03, 2008
Recall Status1 Terminated on October 13, 2010
Recall Number Z-2193-2008
Recall Event ID 48650
Premarket Notification
510(K) Number
K053440 
Premarket Approval
PMA Numbers
P000039 P020024
Product Classification Catheter, Intravascular Occluding, Temporary - Product Code MJN
Product AMPLATZER Sizing Balloon II, REF 9-SB-24. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. A triple lumen balloon catheter with 3 radiopaque marker bands located inside the balloon to allow for radiographic measurement. The center of the balloon contains a pair of marker bands 0.4 mm apart and one marker band 15 mm proximal of that pair. The AMPLATZER Sizing Balloon II is intended for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device.
Code Information lot number M08B11-34
Recalling Firm/
Manufacturer
AGA Medical Corporation
682 Mendelssohn Ave N
Golden Valley, Minnesota 55427-4306
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch. An intact inner pouch seal will maintain device sterility. AGA is asking that customers inspect the specific lot of devices to confirm the integrity of the ou
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action The firm Fed Ex'd and emailed a Field Inspection/Correction letter to customer 04/28/2008. The letter identified affected product, requested that customers check the outer package seal, and if it is incomplete the device should be returned for replacement. A form was also asked to be returned to AGA Medical. Contact AGA Medical at 1-763-513-9227 for assistance.
Quantity in Commerce 131 (34 US, 97 OUS)
Distribution Within the US to include: AL, AZ, CA, CT, FL, IA, ID, MA, MD,MI, MO, NC, NH, NY, OH, PA, SD, TN, TX, WI. OUS to include: Brazil, Greece, Netherlands, Portugal, and Slovakia
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MJN and Original Applicant = AGA MEDICAL CORP.
PMA Database PMAs with Product Code = MJN and Applicant = AGA MEDICAL CORP.
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