Device Recall AMPLATZER Exchange Systems

  • Model / Serial
    M02B14-09, M02C25-16
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Product Description
    AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-6F-180/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    M01L12-10, M03D08-06, M03D08-07, M03L18-54
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Product Description
    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-9F-45/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. 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.
  • Manufacturer
  • Model / Serial
    M01B14-8, M02F05-18, M03A09-69, M03E27-05, M03F18-12
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Product Description
    AMPLATZER Exchange System 45-degree curve, order no. 9-EXCH-12F-45/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. 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.
  • Manufacturer
  • Model / Serial
    M02A28-25, M04D01-06
  • Distribution
    Product has been distributed throughout the US and Internationally, including Canada, Europe and Australia.
  • Product Description
    AMPLATZER Exchange System 180-degree curve, order no. 9-EXCH-8F-180/80. Product is labeled as Sterile EO. || The AMPLATZER Exchange System is comprised of the identical components as the AMPLATZER Delivery System, which is comprised of delivery sheath, delivery cable, dilator, loading device and pin vise. The only exception is the dilator component in the Exchange System has a larger inner lumen to allow passage over an AMPLATZER delivery cable. 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.
  • Manufacturer