FDA-Device2023-07-19Class I
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Abbott
Hazard
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used.
Sold states
Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.
Affected count
675 units
Manufactured in
5050 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2110-2023Don't want to check this manually?
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