Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

Recalled July 19, 2023 · FDA recall Z-2110-2023 · 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. · FDA Class I

Units

675 units

Sold at

Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic.

Description

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.

Product

Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).

Manufacturer(s)

Abbott

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →