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Amplatzer Cardiac Septal Occluder Delivery Systems labeled… recallZ-0255-2007 · AGA Medical Corporation · initiated Oct 2, 2006

Terminated All recalls posted in December 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from AGA Medical Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier. AGA has no confirmed complaints or adverse events related to this failure mode.

FDA root cause category: Other

What the company is doing

An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.

Recall details

Recall number
Z-0255-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 2, 2006
Posted by the FDA
Dec 19, 2006
Recalling firm
AGA Medical Corporation
Quantity
90,516
Product code
GBK
FDA submissions
P020024
Distribution
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.

Product description

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.

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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.

Other devices under the same FDA submission

9 devices cleared under P020024 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 36440).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page