• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall AMPLATZER Delivery System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
AMPLATZER Delivery System
see related information
Date Posted September 03, 2008
Recall Status1 Terminated on October 13, 2010
Recall Number Z-2192-2008
Recall Event ID 48650
Premarket Notification
510(K) Number
K053440 
Premarket Approval
PMA Numbers
P000039 P020024
Product AGA Medical Corporation AMPLATZER Delivery System, 10 French, 45 Degree Angle Curve, 80 Usable Length (cm), REF 9-DEL-10F-45/80. Sterile EO. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Manufactured in U.S.A. The AMPLATZER Delivery System was designed to facilitate attachment, loading, delivery and deployment of the AMPLATZER Septal Occluder and comprised of a delivery sheath, dilator, loading device, plastic vise and delivery cable.
Code Information lot number M07K29-32
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 10 (9 US, 1 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

 
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.
-
-