Device Recall AMPLATZER Delivery Systems

M01K01-6, M02C12-24, M02C25-15, M02F05-23, M02F24-05, M02L02-21, M03A09-10, M03A09-15, M03A20-10, M03B20-17 M03C24-14, M03F02-17, M03G23-08, M03H12-42, 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

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-7F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

M02D26-02, M02I23-02, M02J10-09, M02K07-47, M03C04-06 M03D16-16, M03F18-07, M03K14-07, M03L18-50, M03M03-11 M04C23-10, M04E24-18, M04G01-20

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/60. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

M01J19-12, M02B14-10, M02C12-27, M02D16-19, M02D16-23 M02F24-07, M02G23-04, M02H19-05, M02K07-48, M02K12-10 M02L11-13, M03A09-13, M03A20-11, M03A20-18, M03A22-12 M03B10-56, M03B20-11, M03C24-13, M03D08-08, M03D16-18 M03E27-08, M03F13-07, M03F18-10, M03H12-43, M03J04-12 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, M04F28-47, M04H24-22 M04J07-09, M04J10-22, M04J17-08, M04K15-10, M04L02-02

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-8F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

M01L17-02, M02A28-21, M02A28-24, M02K07-46, M03G10-30,  M03L18-52, M04B09-18, M04C23-13, M04E27-20, M04F08-24,  M04H03-20, M04K26-18

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

AMPLATZER Delivery System 180-degree curve, order no. 9-DEL-8F-180/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.

M01K01-7, M01K28-18, M02C25-24, M02D16-17, M02D16-21,  M02E16-28, M02F05-22, M02F24-08, M02G23-01, M02G23-06,  M02K07-51, M02K12-09, M02K20-06, M02K25-13, M02L02-29,  M02L11-10, M02L11-15, M02L11-17, M03A09-70, M03A27-34,  M03A27-35, M03B10-52, M03B10-55, M03B20-19, M03C13-11,  M03C13-13M03C24-11, M03G09-13, M03G24-19, M03G30-26,  M03H01-02, M03H05-17, M03H05-18, M03H12-40, M03H15-03,  M03H15-05, M03H15-09, M03J02-16, M03J10-08, M03J10-09,  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, M04L05-08

Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.

AMPLATZER Delivery System 45-degree curve, order no. 9-DEL-9F-45/80. Product is labeled as Sterile EO. || Amplatzer Occluder Device and Delivery System is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The Delivery and Exchange Systems are placed onto polyboard backing cards. The backing card is then placed into a smaller of 2 Tyvek pouches. The pouch is then placed inside a larger Tyvek pouch. The kit is assembled at AGA and then sterilized by Steris, Minneapolis, MN.