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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the countries of Slovakia, Czech Republic. Quantity: 675 units Lot/code info: UDI/DI 05415067036025, Batch Numbers: 8597228, 8598983, 8601676, 8611443, 8619197, 8627877, 8650955, 8663679, 8795668, 8815423, 8824607, 8830530, 8846835

UPC codes

05415067036025

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.