Device Recall AMPLATZER Delivery System

Order no. 9-DEL-5F-180/60, Lot Numbers: M03J19-05, M03L18-49, M04B02-02, M04C01-19, M04E18-13, M04J13-15, M04L02-04, M04M28-10, M05C15-31, M05C25-27, M05D29-51, M05G20-44, M05G28-19, M05H30-45, M05J23-32.  Order no. 9-DEL-6F-45/60, Lot Numbers: M03L11-45, M03J23-04, M04B09-16, M04E27-19, M04L22-12, M05A03-10, M05B04-20, M05B08-04, M05C08-23, M05C09-05, M05E24-48, M05H01-51, M05J12-16, M06C20-25, M06D03-02, M06D19-71, M06E22-46.  Order no. 9-DEL-6F-180/80, Lot Numbers: M03K16-22, M03K28-33, M03L11-47, M03M02-09, M03M03-09, M03M12-18, M04A19-31, M04B03-10, M04C01-17, M04C23-12, M04D06-10, M04D13-16, M04E24-16, M04F23-21, M04F28-40, M04G01-22, M04G27-27, M04H03-17, M04H12-11, M04H24-23, M04L08-02, M04M16-21, M04M30-04, M05A03-09, M05A05-27, M05A12-07, M05A17-07, M05A18-04, M05A20-09, M05A27-27, M05A31-06, M05B02-26, M05B21-13, M05B23-09, M05C08-04, M05C25-02, M05D07-08, M05D13-09, M05D14-13, M05G07-20, M05G11-03, M05G12-06, M05G15-24, M05G15-31, M05G27-41, M05H08-19, M05H04-10, M05H05-29, M05H09-09, M05K14-06, M05K20-10, M05K28-02, M05M28-23, M06A13-17, M06D19-53, M06D19-57, M06D19-55, M06D19-59, M06E16-68, M06E22-65, M06E22-67, M06F07-90, M06F13-86.  Order no. 9-DEL-7F-45/60, Lot Numbers: . Order no. , Lot Numbers: M03L12-09, M04C23-09, M04E24-17, M04G01-24, M04M10-18, M05B04-18, M05B07-06, M05B16-02, M05D08-09, M05F13-11, M05G15-16, M05G19-24, M05J08-03.  Order no. 9-DEL-7F-45/80, Lot Numbers: M03J19-07, M03K14-06, M03K28-35, M03L11-48, M04B03-09, M04B03-14, M04C08-12, M04D06-12, M04E11-28, M04E24-20, M04F08-23, M04H03-23, M04J17-07, M04K07-02, M04K28-06, M04L30-04, M05A11-12, M05A11-10, M05A12-05, M05B04-09, M05B16-04, M05B16-23, M05B23-07, M05C10-07, M05C14-07, M05C15-29, M05D04-15, M05E03-02, M05E12-16, M05E12-03, M05E16-21, M05E17-45, M05F01-02, M05F30-25, M05G07-02, M05G21-06, M05G29-23, M05H01-11, M05H17-09, M05J16-13, M05J16-68, M05J28-08, M05K04-04, M05M05-11, M06A13-19, M06C20-23, M06C28-42, M06D04-77, M06D12-20, M06E16-80, M06F01-43, M06F07-88, M06F13-76, M06G25-96.  Order no. 9-DEL-7F-180/80, Lot Numbers: M03K24-14, M03L12-10, M03M12-19, M03G15-34, M04B03-08, M04B09-17, M04C01-18, M04D01-05, M04D06-11, M04D20-07, M04E04-05, M04F08-21, M04H03-18, M04H24-25, M04K22-13, M04L30-12, M04M13-05, M05A18-26, M05A20-11, M05B08-06, M05B14-22, M05B18-10, M05B18-12, M05C16-33, M05C16-18, M05D05-39, M05E11-30, M05E18-04, M05E26-23, M05G08-07, M05G15-29, M05G26-16, M05H02-22, M05H03-11, M05J13-14, M05J19-66, M05J23-07, M05J26-19, M05K19-04, M05L30-22, M05M22-20, M06D19-67, M05D19-69, M06E16-76, M06E22-71, M06E22-69. Order no. 9-DEL-8F-45/60, Lot Numbers: M03K14-07, M03L18-50, M03M03-11, M04C23-10, M04E24-18, M04G01-20, M04L30-02, M04M15-20, M05B07-08, M05B14-04, M05B15-07, M05B24-14, M05B25-06, M05H19-13. Order no. 9-DEL-8F-45/80, Lot Numbers: M03J19-08, M03J25-27, M03K09-23, M03K28-36, M03L11-46, M03M03-12, M03M29-07, M04A19-28, M04A28-16, M04B03-13, M04B09-19, M04B17-33, M04B24-08, M04C23-11, M04D06-13, M04D26-06, M04D26-10, M04F08-22, M04F27-47, M04H24-22, M04J07-09, M04J10-22, M04J17-08, M04J17-09, M04K06-02, M04K11-08, M04K15-10, M04K25-25, M04L02-02, M04L08-12, M04L29-18, M04M01-02, M04M10-08, M04M20-16, M04M22-02, M04M30-05, M05A11-08, M05A18-28, M05A21-20, M05A21-24, M05A24-34, M05A27-13, M05A28-13, M05A31-08, M05B17-04, M05B17-06, M05C21-24, M05C24-04, M05C25-18, M05C30-24, M05C31-28, M05D06-07, M05D12-03, M05D14-09, M05D20-06, M05D25-19, M05D27-20, M05D28-13, M05E24-17, M05E25-21, M05E27-46, M05F06-46, M05F21-43, M05F21-41, M05G20-10, M05G27-39, M05H12-16, M05H17-13, M05H24-19, M05J09-10, M05J09-12, M05K11-03, M05K18-10, M05K20-08, M05K21-05, M05L17-19, M05L21-04, M05L28-04, M05L30-20, M06A09-15, M06A12-10, M06A12-12, M06A20-25, M06A20-27, M06A24-18, M06A20-29, M06C17-36, M06C17-38, M06D04-73, M06D11-05, M06D12-12, M06D12-14, M06D12-16, M06D12-18, M06E22-49, M06E22-51, M06F01-47, M06F07-82, M06F07-84, M06F07-86, M06F13-72, M06F13-74, M06F22-19, M06F29-12, M06G24-46.  Order no. 9-DEL-8F-180/80, Lot Numbers: M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24, M04H03-20, M04K26-18, M04L04-17. M05B11-08, M05C01-06, M05C01-08, M05C11-02, M05E02-21, M05F28-12, M05J01-38, M05J22-28, M05K18-04.  Order no. 9-DEL-9F-45/80, Lot Numbers: M03K14-08, M03K24-15, M03K28-37, M03M02-12, M03M03-08, M03M29-03, M03M29-06, M03M30-13, M04A19-29, M04A28-18, M04B03-12, M04B17-38, M04C08-13, M04C15-04, M04C15-06, M04D06-09, M04D13-17, M04D20-08, M04D26-07, M04D26-09, M04E24-19, M04E27-24, M04F21-43, M04F23-23, M04G27-25, M04H12-12, M04H24-20, M04J22-13, M04K08-02, M04L05-08, M04L19-11, M04L29-02, M04L29-17, M04L29-23, M04L30-10, M04M14-02, M04M14-04, M04M14-21, M04M16-23, M04N22-23, M05A05-25, M05A03-12, M05A11-06, M05A13-19, M05A18-24, M05A19-04, M05A24-09, M05A24-32, M05A24-36, M05A25-19, M05A28-11, M05B01-05, M05B02-24, M05B04-22, M05B10-05, M05B11-06, M05B22-03, M05B23-05, M05B24-20, M05C10-25, M05C15-27, M05C24-02, M05D04-13, M05D06-05, M05D07-04, M05D08-11, M05D12-20, M05D26-26, M05E11-14, M05E11-16, M05E13-09, M05E31-04, M05E31-10, M05E31-12, M05F06-44, M05F03-12, M05F09-06, M05F10-07, M05F14-26, M05F16-17, M05F27-06, M05F29-06, M05G06-07, M05G18-30, M05G19-15, M05G27-07, M05G27-43, M05H01-09, M05H12-14, M05H18-34, M05H19-08, M0530-36, M05J07-10, M05J08-05, M05J16-57, M05L01-02, M05L18-02, M05L30-06, M05M02-21, M05M06-13, M05M08-16, M05M22-12, M05M22-16, M06A09-12, M06A16-23, M06C15-52, M06C20-27, M06C24-22, M06D04-69, M06D04-71, M06D19-61, M06D19-63, M06D21-03, M06D21-05, M06D21-07, M06E22-53, M06E22-55, M06F13-78, M06F29-10, M06G25-93.  Order no. 9-DEL-9F-180/80, Lot Numbers: M03K28-34, M03L18-51, M04L22-14, M05C28-12, M05D07-10, M05E03-13, M05F22-09, M05J26-21. Order no. 9-DEL-10F-45/80, Lot Numbers: M03J25-26, M03K01-02, M03K09-22, M03K14-05, M03K16-16, M03K16-17, M03K24-09, M03L18-56, M03M30-11, M03M30-14, M03M30-15, M04A19-30, M04B03-11, M04B17-34, M04B24-09, M04C30-08, M04F08-20, M04F23-20, M04F28-46, M04G01-19, M04G01-21, M04H23-20, M04H23-21, M04J07-04, M04L29-19, M04L29-20, M04M22-25, M04M17-19, M04M29-09, M04M29-10, M05A03-11, M05A10-07, M05A10-09, M05A14-08, M05B07-24, M05B07-25, M05B07-26, M05B18-06, M05B21-04, M05B24-08, M05C03-08, M05C07-06, M05C10-05, M05C10-27, M05C15-25, M05C23-07, M05C29-13, M05D29-05, M05E04-17, M05E05-24, M05E09-19, M05E09-21, M05E16-19, M05E17-43, M05E24-13, M05E27-38, M05E26-33, M05F09-08, M05F28-08, M05F28-10, M05H03-37, M05H22-06, M05H25-15, M05H25-13, M05J01-13, M05J22-23, M05K10-07, M05K13-04, M05K19-02, M05K21-03, M05L18-04, M05L29-12, M05M02-23, M05M01-05, M05M22-18, M06A13-15, M06C15-55, M06C24-20, M06D04-65, M06D04-67, M06E08-10, M06E08-12, M06F07-80, M06F13-82, M06G25-94. Order no. 9-DEL-12F-45/80, Lot Numbers: M03J25-28, M03K16-21, M03K24-13, M03L18-55, M03M03-13, M03M30-12, M03M30-16, M04A28-19, M04C09-03, M04C09-04, M04C15-05, M04D01-04, M04D06-08, M04D26-08, M04F21-42, M04F23-22, M04G27-26, M04H03-22, M04H24-21, M04J30-02, M04K05-02, M04K25-23, M04L04-09, M04M10-05, M04M23-02, M05A13-03, M05A14-11, M05A19-06, M05B04-24, M05B21-28, M05C03-04, M05C02-06, M05C07-08, M05C08-02, M05C21-25, M05D07-06, M05D15-28, M05D19-02, M05D18-45, M05D25-04, M05D28-23, M05D29-19, M05E02-08, M05E10-29, M05E13-26, M05E19-07, M05E20-17, M05E24-15, M05F07-12, M05F15-35, M05F15-43, M05F20-05, M05F21-54, M05G13-16, M05G25-15, M05G27-09, M05H05-27, M05H26-08, M05H29-16, M05J09-27, M05J12-09, M05J12-07, M05K06-10, M05K07-25, M05K31-28, M06C15-57, M06D04-75, M06D12-10, M06E16-78, M06F01-45, M06F13-84.   the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, Lot numbers: M05K24-25, M05L03-06, M06C03-17, M06C27-05, M06E22-57.  Order no. 9-ITV07F45/60, Lot numbers: M05K24-27, M05L04-13, M06B10-21, M06E01-40, M06F13-96.  Order no. 9-ITV07F45/80, Lot numbers: M05K24-04, M05L10-07, M05L14-13, M05L15-34, M06B01-31, M06C02-14, M06F01-33, M06F07-68, M06F07-70.  Order no. 9-ITV08F45/60, Lot numbers: M05K24-29, M05L03-08, M06B10-25.  Order no. 9-ITV08F45/80, Lot numbers: M05K24-31, M05L11-15, M05M06-17, M05M07-10, M05M12-16, M06A05-25, M06B01-33, M06B10-27, M06B10-23, M06E03-10, M06E03-08, M06E16-84, M06F01-41, M06F13-90, M06G06-18, M06G25-79.  Order no. 9-ITV09F45/80, Lot numbers: M05K24-33, M05L10-09, M05M12-18, M05M12-20, M06A12-19, M06B01-37, M06B10-29, M06C03-14, M06C10-18, M06C10-20, M06C13-38, M06C13-40, M06D19-73, M06D26-26, M06D26-28, M06D26-30, M06F01-39, M06F07-76, M06F07-72, M06F13-98, M06F14-03, M06F22-17, M06F14-01, M06G24-28, M06F22-15.  Order no. 9-ITV10F45/80, Lot numbers: M05K24-06, M05L02-12, M05M07-12, M05M12-22. M06B01-39, M06C02-16, M06C10-22, M06C10-24, M06C13-42, M06C13-44, M06D12-08, M06D12-06, M06F13-92, M06G06-24, M06G06-22.  Order no. 9-ITV12F45/80, Lot numbers: M05K24-35, M05L14-09, M05M05-15, M05M12-24, M06B01-41, M06C02-18, M06C20-39, M06C10-28, M06C10-26, M06D12-01, M06E03-04, M06E09-59, M06G25-89.  Order no. 9-ITV05F180/60, Lot numbers: M05K24-02, M05L02-15, M06C27-07.  Order no. 9-ITV06F180/60, Lot numbers:  Order no. 9-ITV06F180/80, Lot numbers: M05K24-08, M05L03-10, M05L04-15, M05L17-23, M05L28-03, M06C20-29, M06C20-31, M06C27-08, M06C20-33, M06E01-05, M06G06-26.  Order no. 9-ITV07F180/80, Lot numbers: M05K24-10, M05L08-06, M05L15-28, M05L17-25, M06B17-34, M06B21-43, M06B21-45, M06B21-47, M06G24-24.  Order no. 9-ITV08F180/80, Lot numbers: M05K24-23, M05L11-17, M06B17-28, M06D19-65, M06E08-05.  Order no. 9-ITV09F180/80, Lot numbers: M05K24-21, M05L07-06, M06B17-32.

Worldwide, including USA, Puerto Rico, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Moroc, Mexico, Norway, Pakistan, Peru, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, Slovak Republic, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.

Amplatzer Cardiac Septal Occluder Delivery Systems labeled as follows: a) AMPLATZER Delivery System, Order no. 9-DEL-5F-180/60, 9-DEL-6F-45/60, 9-DEL-6F-180/80, 9-DEL-7F-45/60, 9-DEL-7F-45/80, 9-DEL-7F-180/80, 9-DEL-8F-45/60, 9-DEL-8F-45/80, 9-DEL-8F-180/80, 9-DEL-9F-45/80, 9-DEL-9F-180/80, 9-DEL-10F-45/80, 9-DEL-12F-45/80. [Breakdown of order no. ''9-DEL-5F-180/60'' is as follows: 9-DEL, French size (5F) - degree angle curve (180) / usable length in cm (60).] b) the following devices are not approved for US distribution: AMPLATZER TorqVue Delivery System, order no. 9-ITV06F45/60, 9-ITV07F45/60, 9-ITV07F45/80, 9-ITV08F45/60, 9-ITV08F45/80, 9-ITV09F45/80, 9-ITV10F45/80, 9-ITV12F45/80, 9-ITV05F180/60, 9-ITV06F180/80, 9-ITV07F180/80, 9-ITV08F180/80, 9-ITV09F180/80. Manufactured in USA, Sterile EO. Headquarters AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 U.S.A. The Delivery System is comprised of a delivery sheath, delivery cable, dilator, loading device and pin vise.